Cerebral Palsy
Conditions
Keywords
cerebral palsy, amantadine, cognitive function, gross motor skills, fine motor skills, mood
Brief summary
Cerebral palsy (CP) is a common childhood-onset disability associated with motor and cognitive impairments, however most research is focused on motor outcomes. The aim of this study is to determine the effects of Amantadine, a dopaminergic agonist, on cognitive function in adolescents and adults with CP.
Detailed description
CP is a heterogeneous condition due to injury to the developing brain. It is a condition that is often marked by both cognitive and motor disorders as well as increased prevalence of depression and anxiety. While most studies have focused on improving motor dysfunction, fewer have investigated cognitive impairments associated with CP. Dedicating a study to research the pharmacotherapeutic effect of Amantadine on cognitive function in adolescents and adults with cerebral palsy fills an important gap in development of a potential innovative treatment for cognitive deficits. The investigators hope to determine the effects of Amantadine on cognitive function in adolescents and adults with CP. The investigators will also evaluate secondary goals of improving gross and fine motor skills and mood.
Interventions
6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Cerebral Palsy
Exclusion criteria
* Currently pregnant * Unstable seizure condition * Currently taking methadone * Currently taking other dopamine agonists * Currently taking anti-psychotic medication * Previously taken amantadine * Diagnosed with Chronic Kidney Disease (CKD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Brief-A Score | Baseline | The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Both a self-report and an informant report are used. The BRIEF-A includes 75 items within nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. All 75 items are rated in terms of frequency on a 3-point scale: 1 (never), 2 (sometimes), 3 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Composite scores are calculated and are scored from a range of 75 (better outcome) to 225. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean PHQ-9 Score | Baseline | The Patient Health Questionnaire (PHQ-9) is a self-administered, nine-item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 27. A total score of 0-4 indicates minimal depression severity, 5-9 indicates mild depression severity, 10-14 indicates moderate depression severity, 15-19 indicates moderately severe, 20-27 indicates severe depression severity. Therefore, a high score indicates a worse outcome. Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amantadine Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Amantadine Hydrochloride: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Amantadine |
|---|---|
| Age, Customized Ages | 24.8 years STANDARD_DEVIATION 8.3 |
| Cerebral Palsy Diagnosis | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 6 / 11 |
| serious Total, serious adverse events | 1 / 11 |
Outcome results
Primary
Mean Brief-A Score
The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Both a self-report and an informant report are used. The BRIEF-A includes 75 items within nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. All 75 items are rated in terms of frequency on a 3-point scale: 1 (never), 2 (sometimes), 3 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Composite scores are calculated and are scored from a range of 75 (better outcome) to 225.
Time frame: Baseline
Population: Only includes collected data from participants who completed the BRIEF-A at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amantadine | Mean Brief-A Score | 57.4285 T-score | Standard Deviation 8.05 |
Primary
Mean Brief-A Score
The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Both a self-report and an informant report are used. The BRIEF-A includes 75 items within nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. All 75 items are rated in terms of frequency on a 3-point scale: 1 (never), 2 (sometimes), 3 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Composite scores are calculated and are scored from a range of 75 (better outcome) to 225.
Time frame: 3 weeks
Population: Only includes the collected data from participants who completed the BRIEF-A at the 3-week visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amantadine | Mean Brief-A Score | 55.2 T-score | Standard Deviation 9.431 |
Primary
Mean Brief-A Score
The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment. Both a self-report and an informant report are used. The BRIEF-A includes 75 items within nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. All 75 items are rated in terms of frequency on a 3-point scale: 1 (never), 2 (sometimes), 3 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Composite scores are calculated and are scored from a range of 75 (better outcome) to 225.
Time frame: 6 weeks
Population: Only includes the collected data from participants who completed the BRIEF-A at the 6-week visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amantadine | Mean Brief-A Score | 60.2 T-score | Standard Deviation 10.979 |
Secondary
Mean PHQ-9 Score
The Patient Health Questionnaire (PHQ-9) is a self-administered, nine-item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 27. A total score of 0-4 indicates minimal depression severity, 5-9 indicates mild depression severity, 10-14 indicates moderate depression severity, 15-19 indicates moderately severe, 20-27 indicates severe depression severity. Therefore, a high score indicates a worse outcome. Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.
Time frame: Baseline
Population: Only includes the collected data from participants who completed the PH-9 at the baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amantadine | Mean PHQ-9 Score | 4.667 score on a scale | Standard Deviation 4.397 |
Secondary
Mean PHQ-9 Score
The Patient Health Questionnaire (PHQ-9) is a self-administered, nine-item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 27. A total score of 0-4 indicates minimal depression severity, 5-9 indicates mild depression severity, 10-14 indicates moderate depression severity, 15-19 indicates moderately severe, 20-27 indicates severe depression severity. Therefore, a high score indicates a worse outcome. Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.
Time frame: 3 weeks
Population: Only includes the collected data from participants who completed the PH-9 at the 3-week visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amantadine | Mean PHQ-9 Score | 3.14 score on a scale | Standard Deviation 1.726 |
Secondary
Mean PHQ-9 Score
The Patient Health Questionnaire (PHQ-9) is a self-administered, nine-item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 27. A total score of 0-4 indicates minimal depression severity, 5-9 indicates mild depression severity, 10-14 indicates moderate depression severity, 15-19 indicates moderately severe, 20-27 indicates severe depression severity. Therefore, a high score indicates a worse outcome. Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.
Time frame: 6 weeks
Population: Only includes the collected data from participants who completed the PH-9 at the 6-week visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amantadine | Mean PHQ-9 Score | 6.429 score on a scale | Standard Deviation 5.473 |