Trial Outcomes & Findings for Cognitive Effects of Treatment of Interictal Discharges (NCT NCT00916149)
NCT ID: NCT00916149
Last Updated: 2018-10-03
Results Overview
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.
COMPLETED
NA
31 participants
1 and 11 weeks
2018-10-03
Participant Flow
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.
Participant milestones
| Measure |
No Treatment
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
10
|
5
|
|
Overall Study
COMPLETED
|
12
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
0
|
Reasons for withdrawal
| Measure |
No Treatment
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
0
|
|
Overall Study
Unable to place scalp EEG leads
|
1
|
0
|
0
|
Baseline Characteristics
Cognitive Effects of Treatment of Interictal Discharges
Baseline characteristics by cohort
| Measure |
No Treatment
n=15 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=10 Participants
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.
|
Lamotrigine
n=5 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.4 years
n=99 Participants
|
35.8 years
n=107 Participants
|
31.4 years
n=206 Participants
|
35.3 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 and 11 weeksPopulation: In a preliminary analysis, data from 11 healthy controls and 6 subjects with partial-onset epilepsy were evaluated.
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.
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment
|
-28.8 IEDs/hour
Standard Deviation 71.8
|
.54 IEDs/hour
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across measures.
Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score
|
2.45 scores on a scale
Standard Deviation 1.29
|
2.5 scores on a scale
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
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.
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning
|
8.09 number recalled
Standard Deviation 8.79
|
5.5 number recalled
Standard Deviation 6.78
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=5 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay
|
1.27 number recalled
Standard Deviation 2.65
|
-0.4 number recalled
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay
|
1.55 number recalled
Standard Deviation 3.21
|
2.67 number recalled
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
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)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning
|
.45 number recalled
Standard Deviation 1.92
|
.33 number recalled
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
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)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning
|
1.09 number recalled
Standard Deviation 3.05
|
.17 number recalled
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
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)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall
|
.36 number recalled
Standard Deviation .81
|
.33 number recalled
Standard Deviation .52
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: 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.
Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life)
Outcome measures
| Measure |
No Treatment
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE
|
—
|
19.6 scores on a scale
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
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.
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS
|
.18 scores on a scale
Standard Deviation 1.66
|
-0.5 scores on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: 1 and 11 WeeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
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.
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span
|
.36 number recalled
Standard Deviation 3.08
|
-1.67 number recalled
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
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.
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span
|
.73 number recalled
Standard Deviation 4
|
-.33 number recalled
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
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.)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency
|
-1.55 scores on a scale
Standard Deviation 11.26
|
-.83 scores on a scale
Standard Deviation 12.95
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Stroop score (The score is the time for completion in seconds; less time reflects better performance.)
Outcome measures
| Measure |
No Treatment
n=9 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop
|
.98 seconds
Standard Deviation 12.15
|
-7.3 seconds
Standard Deviation 14.19
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
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.)
Outcome measures
| Measure |
No Treatment
n=10 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency
|
2.8 scores on a scale
Standard Deviation 4.52
|
.83 scores on a scale
Standard Deviation 3.97
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Trails Test score (The score is the time for completion in seconds. A lower score reflects better performance.)
Outcome measures
| Measure |
No Treatment
n=10 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test
|
-9.51 seconds
Standard Deviation 18.73
|
11.29 seconds
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Grooved Pegboard Score (The score is the time for completion. A lower score reflects better performance.)
Outcome measures
| Measure |
No Treatment
n=9 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard
|
-4.73 seconds
Standard Deviation 18.9
|
-4.36 seconds
Standard Deviation 23.94
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Digit Symbol Score (The score is the number of items completed. A higher score reflects better performance.)
Outcome measures
| Measure |
No Treatment
n=10 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol
|
3.2 scores on a scale
Standard Deviation 2.78
|
1.5 scores on a scale
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy
|
-0.01 percentage of correct responses
Standard Deviation 0.03
|
.01 percentage of correct responses
Standard Deviation .03
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Continuous Performance Test Score - Reaction Time, measured in seconds (CPT RT; less time reflects better performance)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)
|
1.04 seconds
Standard Deviation 110.54
|
-11.33 seconds
Standard Deviation 52.77
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%)
Outcome measures
| Measure |
No Treatment
n=4 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=1 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy
|
.02 percentage of correct responses
Standard Deviation .01
|
.1 percentage of correct responses
Standard Deviation NA
one one data point obtained, hence no standard deviation can be calculated
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time
|
34.96 seconds
Standard Deviation 51.16
|
.45 seconds
Standard Deviation 95.62
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Verbal Working Memory Accuracy Score (range 0-100%)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy
|
0 percentage of correct responses
Standard Deviation .02
|
-.02 percentage of correct responses
Standard Deviation .02
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Verbal Working Memory Reaction Time Score, with reaction time measured in seconds (indicates processing speed)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time
|
-54.76 seconds
Standard Deviation 112.04
|
-9.36 seconds
Standard Deviation 155.16
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Non-verbal Working Memory Accuracy Score (accuracy ranges from 0-100%)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy
|
-.01 percentage of correct responses
Standard Deviation .03
|
0 percentage of correct responses
Standard Deviation .02
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Non-verbal Working Memory Reaction Time Score (indicates processing speed, with reaction time measured in seconds)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time
|
-31.99 seconds
Standard Deviation 85.18
|
-25.54 seconds
Standard Deviation 131.96
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=5 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy
|
.02 percentage of correct responses
Standard Deviation .11
|
.14 percentage of correct responses
Standard Deviation .27
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Verbal Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=5 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time
|
2.98 seconds
Standard Deviation 93.5
|
-6.1 seconds
Standard Deviation 98.44
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=5 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy
|
.01 percentage of correct responses
Standard Deviation .17
|
.03 percentage of correct responses
Standard Deviation .06
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Facial Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=5 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time
|
-66.76 seconds
Standard Deviation 168.66
|
.61 seconds
Standard Deviation 50.91
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Neurological Disorders Depression Inventory for Epilepsy (NDDIE) score (scores range from 0-24; higher scores indicate greater depressive symptoms)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE
|
0.18 scores on a scale
Standard Deviation 2.52
|
1.5 scores on a scale
Standard Deviation 4.28
|
SECONDARY outcome
Timeframe: 1 and 11 weeksPopulation: Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.
Change in Adverse Events Profile score (scores range from 19-76; higher scores indicate greater side effects)
Outcome measures
| Measure |
No Treatment
n=11 Participants
Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
Levetiracetam
n=6 Participants
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.
|
|---|---|---|
|
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)
|
-1.27 scores on a scale
Standard Deviation 6.75
|
1 scores on a scale
Standard Deviation 9.01
|
Adverse Events
Levetiracetam
Lamotrigine
No Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levetiracetam
n=8 participants at risk
8 individuals with focal-onset epilepsy. These individuals 12will 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.
|
Lamotrigine
n=5 participants at risk
5 individuals with generalized epilepsy. These individuals 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.
|
No Treatment
n=12 participants at risk
12 healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
|
|---|---|---|---|
|
General disorders
Weight loss
|
0.00%
0/8
|
20.0%
1/5 • Number of events 1
|
0.00%
0/12
|
|
Psychiatric disorders
Frustration during cognitive testing
|
0.00%
0/8
|
0.00%
0/5
|
8.3%
1/12 • Number of events 1
|
Additional Information
Beth Leeman-Markowski, MD
VA New York Harbor Healthcare System, NYU
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place