Epilepsy
Conditions
Keywords
Epilepsy, Cognition, Lamictal, Lamotrigine, Keppra, Levetiracetam
Brief summary
The purpose of this study is to determine if levetiracetam (for patients with focal seizures) or lamotrigine (for patients with generalized seizures) reduces the occurrence of interictal discharges. The study investigates the possible correlation between reduction of interictal discharges and improved cognitive performance.
Detailed description
Subjects with seizures will be studied with electroencephalography (EEG) and offered medication for prevention of recurrent seizures. Those with focal seizures will be treated with levetiracetam, and those with generalized seizures will be treated with lamotrigine. Subjects will undergo repeated EEG with concurrent cognitive testing before and after initiation of treatment. The proposed study tests 3 hypotheses: 1. that treatment with levetiracetam will reduce focal interictal epileptiform activity, 2. that treatment with lamotrigine will reduce generalized interictal epileptiform activity, and 3. that the extent of interictal epileptiform activity is inversely associated with performance on neuropsychological batteries and computerized cognitive testing. Repeated cognitive/neuropsychological testing obtained at steady state of the study drug and again after approximately 2 months on the final dosage will serve to evaluate the timecourse of potential cognitive benefits.
Interventions
DRUGlevetiracetam
The dosage of levetiracetam will begin at 500mg twice per day (bid) for the first 4 days, and increase by 500mg every 5 days thereafter until a goal of 1500mg bid is reached. The subject will then remain on levetiracetam at 1500mg bid for 8 weeks, until the conclusion of the study. Medication will be supplied in 500mg tablets, to be taken orally.
DRUGLamotrigine
The drug will be supplied in 25, 100 and 150mg tablets, to be taken orally per the titration schedule below: The regimen will begin at 25mg once per day for the first two weeks, and increase to 50mg once per day during weeks 3 and 4. In week 5, the subject will take 50mg twice per day (bid). The dosage will increase to 50mg in the morning and 100mg at night during week 6. During week 7 the subject will take 100mg bid. During week 8, the subject will take 100mg in the morning and 150mg at night. At week 9, the subject will reach the target dose of 150mg bid. The subject will then remain on lamotrigine at 150mg bid for 7 weeks, until the conclusion of the study.
Sponsors
UCB Young Investigator Research Program
National EpiFellows Foundation
UCB Pharma
GlaxoSmithKline
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-55 years of age * Normal Intelligence Quotient (IQ ≥ 80) as estimated by the Wechsler Test of Adult Reading (WTAR) * Able to give consent * The subject's treating physician is planning to prescribe levetiracetam for focal or lamotrigine for generalized seizure prevention * Either symptomatic or idiopathic seizures.
Exclusion criteria
* Non-native English speaking and/or multilingual * Frequent seizures, since seizures themselves impair cognitive function and present a confounding variable. Subjects may have no more than one seizure or one cluster of seizures per month, with a cluster of seizures including more than one seizure, but between which the patient returns to baseline. The cluster may occur over no more than two consecutive days in one month. * Seizure(s) must not have occurred within 3 days of enrollment and testing. * Those with focal seizures who have evidence of renal disease (creatinine clearance less than 80) will be excluded from participation, as levetiracetam is cleared by the kidney. * Those with focal seizures who have neutrophil counts \<1000/microliter will be excluded from participation, as levetiracetam may lower white blood cell counts. * Those with focal seizures and irritability or mood swings will not be eligible for participation, as levetiracetam may exacerbate these symptoms. This will be determined by self-report, information obtained from the referring physician and medical record. * Those with generalized seizures who have moderate to severe liver dysfunction (Child-Pugh Grades B and C) will be excluded from participation, as lamotrigine is cleared by the liver and the proposed dosing may not be tolerable in this population. This will be determined by self-report, information obtained from the referring physician, a comprehensive metabolic panel (routinely obtained in new-onset seizures) and the medical record. * Subjects who are pregnant will not be eligible to take part in the study, as levetiracetam and lamotrigine are classified as Pregnancy Category C drugs and may pose risk to the fetus. Women of childbearing potential will have a urine pregnancy test prior to participation in the study. The urine pregnancy test will be repeated at the final study visit. Subjects with epilepsy who are of childbearing potential must use acceptable methods of birth control during the study, to be continued until one month after discontinuation of the study drug. If a subject does become pregnant during this time period, she must notify the investigators. * Women who are breastfeeding may not participate in this study. Levetiracetam and lamotrigine may pass into the breastmilk of nursing mothers, posing a risk to the baby. * Hypersensitivity to lamotrigine, levetiracetam or any components of these products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment | 1 and 11 weeks | This descriptive analysis examined the change in interictal discharge rates pre to post-treatment with levetiracetam in subjects with epilepsy and with no treatment in healthy controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score | 1 and 11 weeks | Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning | 1 and 11 weeks | Change in California Verbal Learning Test (CVLT) Total Learning Score (the total learning score is summed across 5 learning trials, range 0-80). Higher scores indicate better memory. Scores on the CVLT reflect the number of words recalled. |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay | 1 and 11 weeks | Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay | 1 and 11 weeks | Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning | 1 and 11 weeks | Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Learning score (the score ranges from 0-6, reflecting the number of shapes recalled on the initial learning trial) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning | 1 and 11 weeks | Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning score (the score is summed across 3 learning trials, score range 0-18, reflecting the total number of shapes recalled) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall | 1 and 11 weeks | Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall score (the score ranges from 0-6, reflecting the number of shapes recalled after a 25 minute delay) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE | 1 and 11 weeks | Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS | 1 and 11 weeks | Change in Letter-Number Sequencing score (LNS; score ranges from 0-21; higher scores indicate better performance). The score reflects the number of items that the subject can correctly recall and place in proper alphabetical and numerical sequence. |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span | 1 and 11 Weeks | Change in Spatial Span score (score ranges from 0-32; higher scores indicate better performance). Scores indicate the number of spatial sequences correctly recalled, forwards and backwards. |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span | 1 and 11 weeks | Change in Digit Span score (score ranges from 0-30; higher scores indicate better performance). Scores indicate the number of digit sequences correctly recalled, forwards and backwards. |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency | 1 and 11 weeks | Change in Verbal Fluency score (Score range: lowest score = 0, with no upper limit, reflecting total number of words generated. Higher scores indicate better performance.) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop | 1 and 11 weeks | Change in Stroop score (The score is the time for completion in seconds; less time reflects better performance.) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency | 1 and 11 weeks | Change in Design Fluency score (Score range: lowest score = 0; there is no upper limit. A higher score reflects more designs generated, hence better performance.) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test | 1 and 11 weeks | Change in Trails Test score (The score is the time for completion in seconds. A lower score reflects better performance.) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT) | 1 and 11 weeks | Change in Continuous Performance Test Score - Reaction Time, measured in seconds (CPT RT; less time reflects better performance) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol | 1 and 11 weeks | Change in Digit Symbol Score (The score is the number of items completed. A higher score reflects better performance.) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy | 1 and 11 weeks | Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy | 1 and 11 weeks | Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time | 1 and 11 weeks | Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy | 1 and 11 weeks | Change in Verbal Working Memory Accuracy Score (range 0-100%) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time | 1 and 11 weeks | Change in Verbal Working Memory Reaction Time Score, with reaction time measured in seconds (indicates processing speed) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy | 1 and 11 weeks | Change in Non-verbal Working Memory Accuracy Score (accuracy ranges from 0-100%) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time | 1 and 11 weeks | Change in Non-verbal Working Memory Reaction Time Score (indicates processing speed, with reaction time measured in seconds) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy | 1 and 11 weeks | Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time | 1 and 11 weeks | Change in Verbal Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy | 1 and 11 weeks | Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time | 1 and 11 weeks | Change in Facial Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE | 1 and 11 weeks | Change in Neurological Disorders Depression Inventory for Epilepsy (NDDIE) score (scores range from 0-24; higher scores indicate greater depressive symptoms) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP) | 1 and 11 weeks | Change in Adverse Events Profile score (scores range from 19-76; higher scores indicate greater side effects) |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard | 1 and 11 weeks | Change in Grooved Pegboard Score (The score is the time for completion. A lower score reflects better performance.) |
Countries
United States
Participant flow
Recruitment details
5 subjects enrolled in the Lamotrigine arm. They underwent study procedures, including EEG. The study aim was to compare subjects with and without frequent discharges on EEG. None of these subjects had frequent discharges, and no additional subjects could be recruited. Hence, planned comparisons could not be made and the data were not analyzed.
Participants by arm
| Arm | Count |
|---|---|
| No Treatment Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control. | 15 |
| Levetiracetam Individuals with epilepsy who will be treated with levetiracetam (LEV). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LEV on discharge frequency, discharge duration, and cognitive task performance. | 10 |
| Lamotrigine Individuals with primary generalized epilepsy, who will be treated with lamotrigine (LMT). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LMT on discharge frequency, discharge duration, and cognitive task performance. | 5 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 0 |
| Overall Study | Unable to place scalp EEG leads | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | No Treatment | Levetiracetam | Lamotrigine | Total |
|---|---|---|---|---|
| Age, Continuous | 31.4 years | 35.8 years | 31.4 years | 35.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 9 Participants | 5 Participants | 25 Participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 4 Participants | 18 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 1 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 5 | 0 / 12 |
| other Total, other adverse events | 0 / 8 | 1 / 5 | 1 / 12 |
| serious Total, serious adverse events | 0 / 8 | 0 / 5 | 0 / 12 |
Outcome results
Primary
Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment
This descriptive analysis examined the change in interictal discharge rates pre to post-treatment with levetiracetam in subjects with epilepsy and with no treatment in healthy controls.
Time frame: 1 and 11 weeks
Population: In a preliminary analysis, data from 11 healthy controls and 6 subjects with partial-onset epilepsy were evaluated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment | -28.8 IEDs/hour | Standard Deviation 71.8 |
| Levetiracetam | Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment | .54 IEDs/hour | Standard Deviation 1.44 |
Comparison: Change in frequency of IEDs/per hour was assessed for each group (levetiracetam and no treatment)p-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)
Change in Adverse Events Profile score (scores range from 19-76; higher scores indicate greater side effects)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP) | -1.27 scores on a scale | Standard Deviation 6.75 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP) | 1 scores on a scale | Standard Deviation 9.01 |
Comparison: This analysis assessed the change in the AEP score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the AEP score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall
Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall score (the score ranges from 0-6, reflecting the number of shapes recalled after a 25 minute delay)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall | .36 number recalled | Standard Deviation 0.81 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall | .33 number recalled | Standard Deviation 0.52 |
Comparison: This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning
Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Learning score (the score ranges from 0-6, reflecting the number of shapes recalled on the initial learning trial)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning | .45 number recalled | Standard Deviation 1.92 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning | .33 number recalled | Standard Deviation 1.63 |
Comparison: This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the no treatment group.p-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the levetiracetam treatment group.p-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning
Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning score (the score is summed across 3 learning trials, score range 0-18, reflecting the total number of shapes recalled)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning | 1.09 number recalled | Standard Deviation 3.05 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning | .17 number recalled | Standard Deviation 2.93 |
Comparison: This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy
Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy | .02 percentage of correct responses | Standard Deviation 0.01 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy | .1 percentage of correct responses | — |
Comparison: This analysis assessed the change in the Choice Accuracy score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time
Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time | 34.96 seconds | Standard Deviation 51.16 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time | .45 seconds | Standard Deviation 95.62 |
Comparison: This analysis assessed the change in the Choice Reaction Time score from pre to post time points in the no treatment groupp-value: 0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy
Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy | -0.01 percentage of correct responses | Standard Deviation 0.03 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy | .01 percentage of correct responses | Standard Deviation 0.03 |
Comparison: This analysis assessed the change in the CPT Accuracy score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the CPT Accuracy score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)
Change in Continuous Performance Test Score - Reaction Time, measured in seconds (CPT RT; less time reflects better performance)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT) | 1.04 seconds | Standard Deviation 110.54 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT) | -11.33 seconds | Standard Deviation 52.77 |
Comparison: This analysis assessed the change in the CPT reaction time from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the CPT reaction time from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay
Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay | 1.55 number recalled | Standard Deviation 3.21 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay | 2.67 number recalled | Standard Deviation 2.16 |
Comparison: This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the no treatment group.p-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the levetiracetam treatment group.p-value: 0.045Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay
Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay | 1.27 number recalled | Standard Deviation 2.65 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay | -0.4 number recalled | Standard Deviation 2.07 |
Comparison: This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the no treatment group.p-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the levetiracetam treatment group.p-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning
Change in California Verbal Learning Test (CVLT) Total Learning Score (the total learning score is summed across 5 learning trials, range 0-80). Higher scores indicate better memory. Scores on the CVLT reflect the number of words recalled.
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning | 8.09 number recalled | Standard Deviation 8.79 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning | 5.5 number recalled | Standard Deviation 6.78 |
Comparison: This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the no treatment group.p-value: 0.016Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the levetiracetam treatment group.p-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score
Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score | 2.45 scores on a scale | Standard Deviation 1.29 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score | 2.5 scores on a scale | Standard Deviation 2.88 |
Comparison: This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the no treatment group.p-value: 0.005Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the levetiracetam group.p-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency
Change in Design Fluency score (Score range: lowest score = 0; there is no upper limit. A higher score reflects more designs generated, hence better performance.)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency | 2.8 scores on a scale | Standard Deviation 4.52 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency | .83 scores on a scale | Standard Deviation 3.97 |
Comparison: This analysis assessed the change in the Design Fluency score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Design Fluency score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span
Change in Digit Span score (score ranges from 0-30; higher scores indicate better performance). Scores indicate the number of digit sequences correctly recalled, forwards and backwards.
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span | .73 number recalled | Standard Deviation 4 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span | -.33 number recalled | Standard Deviation 2.81 |
Comparison: This analysis assessed the change in the Digit Span score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Digit Span score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol
Change in Digit Symbol Score (The score is the number of items completed. A higher score reflects better performance.)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol | 3.2 scores on a scale | Standard Deviation 2.78 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol | 1.5 scores on a scale | Standard Deviation 3.02 |
Comparison: This analysis assessed the change in the Digit Symbol score from pre to post time points in the no treatment groupp-value: 0.014Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Digit Symbol score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy
Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy | .01 percentage of correct responses | Standard Deviation 0.17 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy | .03 percentage of correct responses | Standard Deviation 0.06 |
Comparison: This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time
Change in Facial Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time | -66.76 seconds | Standard Deviation 168.66 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time | .61 seconds | Standard Deviation 50.91 |
Comparison: This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard
Change in Grooved Pegboard Score (The score is the time for completion. A lower score reflects better performance.)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard | -4.73 seconds | Standard Deviation 18.9 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard | -4.36 seconds | Standard Deviation 23.94 |
Comparison: This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS
Change in Letter-Number Sequencing score (LNS; score ranges from 0-21; higher scores indicate better performance). The score reflects the number of items that the subject can correctly recall and place in proper alphabetical and numerical sequence.
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS | .18 scores on a scale | Standard Deviation 1.66 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS | -0.5 scores on a scale | Standard Deviation 1.98 |
Comparison: This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE
Change in Neurological Disorders Depression Inventory for Epilepsy (NDDIE) score (scores range from 0-24; higher scores indicate greater depressive symptoms)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE | 0.18 scores on a scale | Standard Deviation 2.52 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE | 1.5 scores on a scale | Standard Deviation 4.28 |
Comparison: This analysis assessed the change in the NDDIE score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the NDDIE score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy
Change in Non-verbal Working Memory Accuracy Score (accuracy ranges from 0-100%)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy | -.01 percentage of correct responses | Standard Deviation 0.03 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy | 0 percentage of correct responses | Standard Deviation 0.02 |
Comparison: This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time
Change in Non-verbal Working Memory Reaction Time Score (indicates processing speed, with reaction time measured in seconds)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time | -31.99 seconds | Standard Deviation 85.18 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time | -25.54 seconds | Standard Deviation 131.96 |
Comparison: This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE
Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. The QOLIE is specific to epilepsy and was only administered in that subject group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE | 19.6 scores on a scale | Standard Deviation 27.8 |
Comparison: This analysis assessed the change in the QOLIE score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span
Change in Spatial Span score (score ranges from 0-32; higher scores indicate better performance). Scores indicate the number of spatial sequences correctly recalled, forwards and backwards.
Time frame: 1 and 11 Weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span | .36 number recalled | Standard Deviation 3.08 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span | -1.67 number recalled | Standard Deviation 1.51 |
Comparison: This analysis assessed the change in the Spatial Span score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Spatial Span score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop
Change in Stroop score (The score is the time for completion in seconds; less time reflects better performance.)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop | .98 seconds | Standard Deviation 12.15 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop | -7.3 seconds | Standard Deviation 14.19 |
Comparison: This analysis assessed the change in Stroop performance from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in Stroop performance from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test
Change in Trails Test score (The score is the time for completion in seconds. A lower score reflects better performance.)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test | -9.51 seconds | Standard Deviation 18.73 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test | 11.29 seconds | Standard Deviation 16.4 |
Comparison: This analysis assessed the change in performance on the Trails Test from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in performance on the Trails Test from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency
Change in Verbal Fluency score (Score range: lowest score = 0, with no upper limit, reflecting total number of words generated. Higher scores indicate better performance.)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency | -1.55 scores on a scale | Standard Deviation 11.26 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency | -.83 scores on a scale | Standard Deviation 12.95 |
Comparison: This analysis assessed the change in the Verbal Fluency score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Verbal Fluency score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy
Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy | .02 percentage of correct responses | Standard Deviation 0.11 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy | .14 percentage of correct responses | Standard Deviation 0.27 |
Comparison: This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time
Change in Verbal Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time | 2.98 seconds | Standard Deviation 93.5 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time | -6.1 seconds | Standard Deviation 98.44 |
Comparison: This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy
Change in Verbal Working Memory Accuracy Score (range 0-100%)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy | 0 percentage of correct responses | Standard Deviation 0.02 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy | -.02 percentage of correct responses | Standard Deviation 0.02 |
Comparison: This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment groupp-value: 0.039Wilcoxon Signed Ranks Test
Secondary
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time
Change in Verbal Working Memory Reaction Time Score, with reaction time measured in seconds (indicates processing speed)
Time frame: 1 and 11 weeks
Population: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time | -54.76 seconds | Standard Deviation 112.04 |
| Levetiracetam | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time | -9.36 seconds | Standard Deviation 155.16 |
Comparison: This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the no treatment groupp-value: >0.05Wilcoxon Signed Ranks Test
Comparison: This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment groupp-value: >0.05Wilcoxon Signed Ranks Test