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| Name | Class |
|---|---|
| UCB Young Investigator Research Program | UNKNOWN |
| National EpiFellows Foundation | UNKNOWN |
| UCB Pharma | INDUSTRY |
| GlaxoSmithKline |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Active Comparator | 12 individuals with epilepsy, 6 of whom experience infrequent focal epileptiform discharges and 6 of whom experience frequent focal discharges. These individuals 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 | Active Comparator | 12 individuals with epilepsy, 6 of whom experience infrequent generalized discharges and 6 of whom experience frequent generalized discharges. 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 | No Intervention | 15 healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levetiracetam | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 and 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 and 11 weeks |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel B Hoch, M.D., Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6421454 | Background | Aarts JH, Binnie CD, Smit AM, Wilkins AJ. Selective cognitive impairment during focal and generalized epileptiform EEG activity. Brain. 1984 Mar;107 ( Pt 1):293-308. doi: 10.1093/brain/107.1.293. | |
| 4858089 | Background | Browne TR, Penry JK, Proter RJ, Dreifuss FE. Responsiveness before, during, and after spike-wave paroxysms. Neurology. 1974 Jul;24(7):659-65. doi: 10.1212/wnl.24.7.659. No abstract available. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Treatment | Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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16 controls enrolled in "no treatment"; 1 subject did not perform tests due to vision loss and difficulty placing EEG leads. Hence, there are 15 subjects in the "no treatment" arm.
We were unable to recruit any subjects with generalized epilepsy and frequent discharges, hence we did not complete the analysis of this arm as planned.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Treatment | Healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | In a preliminary analysis, data from 11 healthy controls and 6 subjects with partial-onset epilepsy were evaluated. | Posted | Mean | Standard Deviation | IEDs/hour | 1 and 11 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight loss | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Leeman-Markowski, MD | VA New York Harbor Healthcare System, NYU | 212-686-7500 | beth.leeman-markowski@nyumc.org |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| INDUSTRY |
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|
|
| Lamotrigine | Drug | 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. |
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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. |
| 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 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. | 1 and 11 weeks |
| 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. | 1 and 11 Weeks |
| 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. | 1 and 11 weeks |
| 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.) | 1 and 11 weeks |
| 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.) | 1 and 11 weeks |
| 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.) | 1 and 11 weeks |
| 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.) | 1 and 11 weeks |
| 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.) | 1 and 11 weeks |
| 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.) | 1 and 11 weeks |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy | Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy | Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy | Change in Verbal Working Memory Accuracy Score (range 0-100%) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 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%) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy | Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy | Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 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) | 1 and 11 weeks |
| 819859 | Background | Dodrill CB, Wilkus RJ. Relationships between intelligence and electroencephalographic epileptiform activity in adult epileptics. Neurology. 1976 Jun;26(6 PT 1):525-31. doi: 10.1212/wnl.26.6.525. |
| 14692914 | Background | Gallagher MJ, Eisenman LN, Brown KM, Erbayat-Altay E, Hecimovic H, Fessler AJ, Attarian HP, Gilliam FG. Levetiracetam reduces spike-wave density and duration during continuous EEG monitoring in patients with idiopathic generalized epilepsy. Epilepsia. 2004 Jan;45(1):90-1. doi: 10.1111/j.0013-9580.2004.39503.x. No abstract available. |
| 5276416 | Background | Goode DJ, Penry JK, Dreifuss FE. Effects of paroxysmal spike-wave on continuous visual-motor performance. Epilepsia. 1970 Sep;11(3):241-54. doi: 10.1111/j.1528-1157.1970.tb03888.x. No abstract available. |
| 8822692 | Background | Hermann BP, Seidenberg M, Schoenfeld J, Peterson J, Leveroni C, Wyler AR. Empirical techniques for determining the reliability, magnitude, and pattern of neuropsychological change after epilepsy surgery. Epilepsia. 1996 Oct;37(10):942-50. doi: 10.1111/j.1528-1157.1996.tb00531.x. |
| 13248285 | Background | HOVEY HB, KOOI KA. Transient disturbances of thought processes and epilepsy. AMA Arch Neurol Psychiatry. 1955 Sep;74(3):287-91. doi: 10.1001/archneurpsyc.1955.02330150053007. No abstract available. |
| 2439294 | Background | Kasteleijn-Nolst Trenite DG, Riemersma JB, Binnie CD, Smit AM, Meinardi H. The influence of subclinical epileptiform EEG discharges on driving behaviour. Electroencephalogr Clin Neurophysiol. 1987 Aug;67(2):167-70. doi: 10.1016/0013-4694(87)90040-x. |
| 13457501 | Background | KOOI KA, HOVEY HB. Alterations in mental function and paroxysmal cerebral activity. AMA Arch Neurol Psychiatry. 1957 Sep;78(3):264-71. No abstract available. |
| 12614389 | Background | Lee S, Sziklas V, Andermann F, Farnham S, Risse G, Gustafson M, Gates J, Penovich P, Al-Asmi A, Dubeau F, Jones-Gotman M. The effects of adjunctive topiramate on cognitive function in patients with epilepsy. Epilepsia. 2003 Mar;44(3):339-47. doi: 10.1046/j.1528-1157.2003.27402.x. |
| 16266826 | Background | Lutz MT, Helmstaedter C. EpiTrack: tracking cognitive side effects of medication on attention and executive functions in patients with epilepsy. Epilepsy Behav. 2005 Dec;7(4):708-14. doi: 10.1016/j.yebeh.2005.08.015. Epub 2005 Nov 2. |
| 15985582 | Background | Meador KJ, Loring DW, Vahle VJ, Ray PG, Werz MA, Fessler AJ, Ogrocki P, Schoenberg MR, Miller JM, Kustra RP. Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology. 2005 Jun 28;64(12):2108-14. doi: 10.1212/01.WNL.0000165994.46777.BE. |
| Background | The Psychological Corporation. Wechsler Test of Adult Reading. 2001, San Antonio, TX: Harcourt Assessment |
| Background | Schwab RS. Research Publications. Reaction time in petit mal epilepsy. Association for Research in Nervous and Mental Disease 1947; 26:339-341. |
| Background | Selldén U. Psychotechnical performance related to paroxysmal discharges in EEG. Clinical Electroencephalography 1971; 2:18-27. |
| 2450731 | Background | Shewmon DA, Erwin RJ. The effect of focal interictal spikes on perception and reaction time. I. General considerations. Electroencephalogr Clin Neurophysiol. 1988 Apr;69(4):319-37. doi: 10.1016/0013-4694(88)90004-1. |
| 2450732 | Background | Shewmon DA, Erwin RJ. The effect of focal interictal spikes on perception and reaction time. II. Neuroanatomic specificity. Electroencephalogr Clin Neurophysiol. 1988 Apr;69(4):338-52. doi: 10.1016/0013-4694(88)90005-3. |
| Background | Synder, P.J. Epilepsy. In Snyder, P.J. & Nussbaum, P.D, Clinical neuropsychology: a pocket handbook for assessment. 1998, Washington DC: American Psychological Association. |
| 11792161 | Background | Stodieck S, Steinhoff BJ, Kolmsee S, van Rijckevorsel K. Effect of levetiracetam in patients with epilepsy and interictal epileptiform discharges. Seizure. 2001 Dec;10(8):583-7. doi: 10.1053/seiz.2001.0582. |
| 12707428 | Background | Stroup E, Langfitt J, Berg M, McDermott M, Pilcher W, Como P. Predicting verbal memory decline following anterior temporal lobectomy (ATL). Neurology. 2003 Apr 22;60(8):1266-73. doi: 10.1212/01.wnl.0000058765.33878.0d. |
| 14043044 | Background | TIZARD B, MARGERISON JH. THE RELATIONSHIP BETWEEN GENERALIZED PAROXYSMAL E.E.G. DISCHARGES AND VARIOUS TEST SITUATIONS IN TWO EPILEPTIC PATIENTS. J Neurol Neurosurg Psychiatry. 1963 Aug;26(4):308-13. doi: 10.1136/jnnp.26.4.308. No abstract available. |
| Background | Tizard B, Margerison JH. Psychological functions during wave-spike discharge. British Journal of Social and Clinical Psychology 1963b; 3:6-15. |
| 12886976 | Background | Tromp SC, Weber JW, Aldenkamp AP, Arends J, vander Linden I, Diepman L. Relative influence of epileptic seizures and of epilepsy syndrome on cognitive function. J Child Neurol. 2003 Jun;18(6):407-12. doi: 10.1177/08830738030180060501. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across measures. | Posted | Mean | Standard Deviation | scores on a scale | 1 and 11 weeks |
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| 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. | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | number recalled | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | number recalled | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | number recalled | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | number recalled | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | number recalled | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | number recalled | 1 and 11 weeks |
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| 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) | 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. | Posted | Mean | Standard Deviation | scores on a scale | 1 and 11 weeks |
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| 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. | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | scores on a scale | 1 and 11 weeks |
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| 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. | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | number recalled | 1 and 11 Weeks |
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| 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. | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | number recalled | 1 and 11 weeks |
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| 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.) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | scores on a scale | 1 and 11 weeks |
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| 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.) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | seconds | 1 and 11 weeks |
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| 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.) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | scores on a scale | 1 and 11 weeks |
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| 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.) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | seconds | 1 and 11 weeks |
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| 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.) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | seconds | 1 and 11 weeks |
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| 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.) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | scores on a scale | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | percentage of correct responses | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | seconds | 1 and 11 weeks |
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| 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%) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | percentage of correct responses | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | seconds | 1 and 11 weeks |
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| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy | Change in Verbal Working Memory Accuracy Score (range 0-100%) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | percentage of correct responses | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | seconds | 1 and 11 weeks |
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| 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%) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | percentage of correct responses | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | seconds | 1 and 11 weeks |
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| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy | Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | percentage of correct responses | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | seconds | 1 and 11 weeks |
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| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy | Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | percentage of correct responses | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | seconds | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | scores on a scale | 1 and 11 weeks |
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| 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) | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | Posted | Mean | Standard Deviation | scores on a scale | 1 and 11 weeks |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Lamotrigine | 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. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG002 | No Treatment | 12 healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control. | 0 | 12 | 0 | 12 | 1 | 12 |
| Frustration during cognitive testing | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014227 | Triazines |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| 0.045 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| 0.039 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |
| Wilcoxon Signed Ranks Test |
| >0.05 |
| Other |