Epilepsy
Conditions
Keywords
Seizure, Antiseizure medications, Seizure Free, Feasibility, Acceptability, Discontinue medication
Brief summary
The main purpose of this study is to understand the effects of continuing versus discontinuing antiseizure medications after a period of seizure-freedom. Physician guidelines endorse that after a period of seizure-freedom, the risk of another seizure may be low enough to allow patients to consider coming off antiseizure medication to see if they still need it. However, evidence is limited regarding how much continuing antiseizure medication still reduces seizures versus increases side effects after a patient has been treated for a while. This study will determine whether discontinuing antiseizure medications benefits patients.
Interventions
DRUGDiscontinue antiseizure medications
Discontinue 1 antiseizure medication. Patients will discontinue 1 of their current antiseizure medications, reducing by 25% every approximately 2 weeks in the discontinuation group or with an individualized taper plan agreed. Participants will attend approximately 5 study visits: once at the beginning, and then four quarterly visits. Each visit may last approximately 1-2 hours. These visits would be conducted by Zoom, unless participants want to conduct visits in-person or need to conduct over the phone.
Sponsors
University of Michigan
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Diagnosis of epilepsy * At least 2 years since participants most recent seizure * At most 35% calculated 1-year post-discontinuation seizure risk, based upon the existing multivariable calculator if they are on only 1 ASM, otherwise no such restriction if they are more than 1 ASM * Willingness to adhere to the study intervention * Taking at least 1 antiseizure medication prior to enrollment
Exclusion criteria
* Current pregnancy or planned pregnancy during the study period * History of epilepsy surgery * Large space-occupying radiographic lesion such as a large cortical tumor, large artery stroke, or encephalomalacia from traumatic brain injury. * Subject has any other clinically significant conditions or circumstances that in the judgment of the investigator or treating clinician should preclude study participation. Please note: The researchers will ask participants not to drive for 2 months after ASM discontinuation if on monotherapy, and exercise caution while driving if stopping one antiseizure medication but remaining on others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients recruited per year | Recruitment Period (approximately 2 years) | The researchers will observe the number of patients who consented divided by the number of patients who were eligible |
| Number of planned study visits attended per patient within 1 year of follow-up for each patient | 1 year | — |
| Number of patients who adhere to the assigned treatment protocol within 1 year for each patient | 1 year | the number of patients who tapered off their antiseizure medication (ASM) within 2 months of consent or started tapering off their ASM but had a seizure before being able to fully taper off |
| Qualitative feedback per exit interview at 1 year | 1 year | This will entail a 30-minute qualitative discussion with the patient and caregivers if applicable to receive any feedback about study procedures. The study will ask patients and caregivers what went well, what could be improved, what participants thought of recruitment and retention and data collection procedures, and the intervention. Responses will be purely qualitative via a discussion with the patient and summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in Epilepsy-31 scale (QOLIE) | 3 months and 1 year | This is a survey of health-related quality of life for adults aged ≥18 years diagnosed with epilepsy. The self-reported questionnaire contains 7 multi-item sub-scales that cover the following health concepts: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life. A total of 31 items are measured using Likert scales and scored by weighting and summing each item. The score ranges 0-100, with higher scores indicating better quality of life. |
| Beck Depression Inventory-II (BDI-II) | 3 months and 1 year | This is a 21-item multiple-choice self-report inventory used to measure the severity of depression symptoms according to criteria listed in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Items include statements relating to sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss in interest in sex. Participants will respond to each item based on a 2-week time period, using a 4-point scale from 0 to 3. A score of 0 to 13 indicates minimal depression, 14 to 19 indicates mild depression, 20 to 28 moderate depression, and 29 to 63 indicates severe depression. |
| Generalized Anxiety Disorder-7 (GAD-7) | 3 months and 1 year | The GAD is a 7-item self-reported screening tool that measures the severity of generalized anxiety disorder symptoms. The 7 items assess feeling nervous/anxious, being able to stop worrying, worrying too much, trouble relaxing, being restless, becoming easily annoyed/irritable, and feeling afraid something awful might happen. Participants will respond to each item based on a 2-week time period, using a 4-point scale from 0 to 3. A score of 0 to 4 indicates minimal anxiety, 5 to 9 indicates mild anxiety, 10 to 14 indicates moderate anxiety, and 15 to 21 indicates severe anxiety. |
| Patient Global Impression-Change scale (PGI-C) | 3 months and 1 year | The Patient Global Impression-Change scale is a self-reported scale that will be used to assess perception of change in participants overall status since baseline using a 7-point Likert scale, anchored at 1= "very much improved" and 7= "very much worse". |
| Verbal memory immediate recall | 3 months and 1 year | This measures recognition memory for words. Fifteen words are presented, one by one, on the screen every 2 seconds. For immediate recognition, the participant has to identify those words nested among fifteen new words. The test is scored by the number of correct hits out of 15. |
| Verbal memory delayed recall | 3 months and 1 year | Verbal memory delayed recall: After 6 more tests, there is a delayed recognition trial of the original words from the immediate recall test. The test is scored by the number of correct hits out of 15. |
| Visual memory immediate recall | 3 months and 1 year | This measures recognition memory for figures or shapes. The protocol is similar to the verbal memory test. Fifteen geometric figures are presented, one by one, on the screen. For immediate recognition, the participant has to identify those figures nested among 15 new figures. The test is scored by the number of correct hits out of 15. |
| Visual memory delayed recall | 3 months and 1 year | Visual memory delayed recall: The protocol is similar to the verbal memory test. After 5 more tests, there is a delayed recognition trial. The test is scored by the number of correct hits out of 15. |
| Symbol digit coding | 3 months and 1 year | This test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The participant types in the number that corresponds to the symbol that is highlighted. Only the digits 2-9 are used, to avoid confusion between "1" and "I" on the keyboard. The computer program does not allow a person to use a numerical pad, preventing a distinct advantage for those who are skilled at using the numerical pad or for those that are right- versus left-handed. Tasks continue for about 4 minutes. The test is scored as the number of correct responses within the time limit, ranging from 0 to as many correct responses as they can achieve. |
| Shifting attention test | 1 year | This is a measure of ability to shift from one instruction set to another quickly and accurately. Participants are instructed to match geometric objects either by shape or by color. Three figures appear on the screen, one on top and 2 on the bottom. The top figure is either a square or a circle. The bottom figures are a square and a circle. The figures are either red or blue (mixed randomly). The participant is asked to match one of the bottom figures to the top figure. The rules change at random (i.e., match the figures by shape, for another, by color). The task continues for about 2.5 minutes. The test is scored as the number of correct responses and errors within the timeframe, ranging from 0 to as many correct responses as participants can achieve. |
| Number of seizures recorded after starting the study by 1 year. | 1 year | — |
| Number of emergency room visits for seizures after starting the study by 1 year. | 1 year | — |
| Number of inpatient visits for seizures after starting the study by 1 year. | 1 year | — |
Countries
United States
Contacts
CONTACTSamuel Terman, MD, MS
PRINCIPAL_INVESTIGATORSamuel Terman, MD, MS
University of Michigan
Outcome results
None listed