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Cognitive Effects of Treatment of Interictal Discharges

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
levetiracetam
Lamotrigine
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Cognition, Lamictal, Lamotrigine, Keppra, Levetiracetam

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • 18-55 years of age
  • Normal Intelligence Quotient (IQ ≥ 80) as estimated by the Wechsler Test of Adult Reading (WTAR)
  • Able to give consent
  • The subject's treating physician is planning to prescribe levetiracetam for focal or lamotrigine for generalized seizure prevention
  • Either symptomatic or idiopathic seizures.

Exclusion Criteria:

  • Non-native English speaking and/or multilingual
  • Frequent seizures, since seizures themselves impair cognitive function and present a confounding variable. Subjects may have no more than one seizure or one cluster of seizures per month, with a cluster of seizures including more than one seizure, but between which the patient returns to baseline. The cluster may occur over no more than two consecutive days in one month.
  • Seizure(s) must not have occurred within 3 days of enrollment and testing.
  • Those with focal seizures who have evidence of renal disease (creatinine clearance less than 80) will be excluded from participation, as levetiracetam is cleared by the kidney.
  • Those with focal seizures who have neutrophil counts <1000/microliter will be excluded from participation, as levetiracetam may lower white blood cell counts.
  • Those with focal seizures and irritability or mood swings will not be eligible for participation, as levetiracetam may exacerbate these symptoms. This will be determined by self-report, information obtained from the referring physician and medical record.
  • Those with generalized seizures who have moderate to severe liver dysfunction (Child-Pugh Grades B and C) will be excluded from participation, as lamotrigine is cleared by the liver and the proposed dosing may not be tolerable in this population. This will be determined by self-report, information obtained from the referring physician, a comprehensive metabolic panel (routinely obtained in new-onset seizures) and the medical record.
  • Subjects who are pregnant will not be eligible to take part in the study, as levetiracetam and lamotrigine are classified as Pregnancy Category C drugs and may pose risk to the fetus. Women of childbearing potential will have a urine pregnancy test prior to participation in the study. The urine pregnancy test will be repeated at the final study visit. Subjects with epilepsy who are of childbearing potential must use acceptable methods of birth control during the study, to be continued until one month after discontinuation of the study drug. If a subject does become pregnant during this time period, she must notify the investigators.
  • Women who are breastfeeding may not participate in this study. Levetiracetam and lamotrigine may pass into the breastmilk of nursing mothers, posing a risk to the baby.
  • Hypersensitivity to lamotrigine, levetiracetam or any components of these products

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Levetiracetam

Lamotrigine

No treatment

Arm Description

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.

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.

15 healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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)
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)
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)
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)
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)
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)
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.
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.
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.
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.)
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.)
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.)
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.)
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.)
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.)
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy
Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct)
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)
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy
Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%)
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time
Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance)
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy
Change in Verbal Working Memory Accuracy Score (range 0-100%)
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)
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%)
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)
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy
Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%)
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)
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy
Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%)
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)
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)
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)

Full Information

First Posted
June 5, 2009
Last Updated
September 5, 2018
Sponsor
Massachusetts General Hospital
Collaborators
UCB Young Investigator Research Program, National EpiFellows Foundation, UCB Pharma, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00916149
Brief Title
Cognitive Effects of Treatment of Interictal Discharges
Official Title
Cognitive Effects of Treatment of Interictal Discharges
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
UCB Young Investigator Research Program, National EpiFellows Foundation, UCB Pharma, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if levetiracetam (for patients with focal seizures) or lamotrigine (for patients with generalized seizures) reduces the occurrence of interictal discharges. The study investigates the possible correlation between reduction of interictal discharges and improved cognitive performance.
Detailed Description
Subjects with seizures will be studied with electroencephalography (EEG) and offered medication for prevention of recurrent seizures. Those with focal seizures will be treated with levetiracetam, and those with generalized seizures will be treated with lamotrigine. Subjects will undergo repeated EEG with concurrent cognitive testing before and after initiation of treatment. The proposed study tests 3 hypotheses: 1. that treatment with levetiracetam will reduce focal interictal epileptiform activity, 2. that treatment with lamotrigine will reduce generalized interictal epileptiform activity, and 3. that the extent of interictal epileptiform activity is inversely associated with performance on neuropsychological batteries and computerized cognitive testing. Repeated cognitive/neuropsychological testing obtained at steady state of the study drug and again after approximately 2 months on the final dosage will serve to evaluate the timecourse of potential cognitive benefits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Cognition, Lamictal, Lamotrigine, Keppra, Levetiracetam

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lamotrigine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
15 healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
Intervention Type
Drug
Intervention Name(s)
levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Other Intervention Name(s)
Lamictal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment
Description
This descriptive analysis examined the change in interictal discharge rates pre to post-treatment with levetiracetam in subjects with epilepsy and with no treatment in healthy controls.
Time Frame
1 and 11 weeks
Secondary Outcome Measure Information:
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score
Description
Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning
Description
Change in California Verbal Learning Test (CVLT) Total Learning Score (the total learning score is summed across 5 learning trials, range 0-80). Higher scores indicate better memory. Scores on the CVLT reflect the number of words recalled.
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay
Description
Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay
Description
Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning
Description
Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Learning score (the score ranges from 0-6, reflecting the number of shapes recalled on the initial learning trial)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning
Description
Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning score (the score is summed across 3 learning trials, score range 0-18, reflecting the total number of shapes recalled)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall
Description
Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall score (the score ranges from 0-6, reflecting the number of shapes recalled after a 25 minute delay)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE
Description
Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS
Description
Change in Letter-Number Sequencing score (LNS; score ranges from 0-21; higher scores indicate better performance). The score reflects the number of items that the subject can correctly recall and place in proper alphabetical and numerical sequence.
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span
Description
Change in Spatial Span score (score ranges from 0-32; higher scores indicate better performance). Scores indicate the number of spatial sequences correctly recalled, forwards and backwards.
Time Frame
1 and 11 Weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span
Description
Change in Digit Span score (score ranges from 0-30; higher scores indicate better performance). Scores indicate the number of digit sequences correctly recalled, forwards and backwards.
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency
Description
Change in Verbal Fluency score (Score range: lowest score = 0, with no upper limit, reflecting total number of words generated. Higher scores indicate better performance.)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop
Description
Change in Stroop score (The score is the time for completion in seconds; less time reflects better performance.)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency
Description
Change in Design Fluency score (Score range: lowest score = 0; there is no upper limit. A higher score reflects more designs generated, hence better performance.)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test
Description
Change in Trails Test score (The score is the time for completion in seconds. A lower score reflects better performance.)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard
Description
Change in Grooved Pegboard Score (The score is the time for completion. A lower score reflects better performance.)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol
Description
Change in Digit Symbol Score (The score is the number of items completed. A higher score reflects better performance.)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy
Description
Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)
Description
Change in Continuous Performance Test Score - Reaction Time, measured in seconds (CPT RT; less time reflects better performance)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy
Description
Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time
Description
Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy
Description
Change in Verbal Working Memory Accuracy Score (range 0-100%)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time
Description
Change in Verbal Working Memory Reaction Time Score, with reaction time measured in seconds (indicates processing speed)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy
Description
Change in Non-verbal Working Memory Accuracy Score (accuracy ranges from 0-100%)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time
Description
Change in Non-verbal Working Memory Reaction Time Score (indicates processing speed, with reaction time measured in seconds)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy
Description
Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time
Description
Change in Verbal Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy
Description
Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time
Description
Change in Facial Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE
Description
Change in Neurological Disorders Depression Inventory for Epilepsy (NDDIE) score (scores range from 0-24; higher scores indicate greater depressive symptoms)
Time Frame
1 and 11 weeks
Title
Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)
Description
Change in Adverse Events Profile score (scores range from 19-76; higher scores indicate greater side effects)
Time Frame
1 and 11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 18-55 years of age Normal Intelligence Quotient (IQ ≥ 80) as estimated by the Wechsler Test of Adult Reading (WTAR) Able to give consent The subject's treating physician is planning to prescribe levetiracetam for focal or lamotrigine for generalized seizure prevention Either symptomatic or idiopathic seizures. Exclusion Criteria: Non-native English speaking and/or multilingual Frequent seizures, since seizures themselves impair cognitive function and present a confounding variable. Subjects may have no more than one seizure or one cluster of seizures per month, with a cluster of seizures including more than one seizure, but between which the patient returns to baseline. The cluster may occur over no more than two consecutive days in one month. Seizure(s) must not have occurred within 3 days of enrollment and testing. Those with focal seizures who have evidence of renal disease (creatinine clearance less than 80) will be excluded from participation, as levetiracetam is cleared by the kidney. Those with focal seizures who have neutrophil counts <1000/microliter will be excluded from participation, as levetiracetam may lower white blood cell counts. Those with focal seizures and irritability or mood swings will not be eligible for participation, as levetiracetam may exacerbate these symptoms. This will be determined by self-report, information obtained from the referring physician and medical record. Those with generalized seizures who have moderate to severe liver dysfunction (Child-Pugh Grades B and C) will be excluded from participation, as lamotrigine is cleared by the liver and the proposed dosing may not be tolerable in this population. This will be determined by self-report, information obtained from the referring physician, a comprehensive metabolic panel (routinely obtained in new-onset seizures) and the medical record. Subjects who are pregnant will not be eligible to take part in the study, as levetiracetam and lamotrigine are classified as Pregnancy Category C drugs and may pose risk to the fetus. Women of childbearing potential will have a urine pregnancy test prior to participation in the study. The urine pregnancy test will be repeated at the final study visit. Subjects with epilepsy who are of childbearing potential must use acceptable methods of birth control during the study, to be continued until one month after discontinuation of the study drug. If a subject does become pregnant during this time period, she must notify the investigators. Women who are breastfeeding may not participate in this study. Levetiracetam and lamotrigine may pass into the breastmilk of nursing mothers, posing a risk to the baby. Hypersensitivity to lamotrigine, levetiracetam or any components of these products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel B Hoch, M.D., Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6421454
Citation
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.
Results Reference
background
PubMed Identifier
4858089
Citation
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.
Results Reference
background
PubMed Identifier
819859
Citation
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.
Results Reference
background
PubMed Identifier
14692914
Citation
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.
Results Reference
background
PubMed Identifier
5276416
Citation
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.
Results Reference
background
PubMed Identifier
8822692
Citation
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.
Results Reference
background
PubMed Identifier
13248285
Citation
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.
Results Reference
background
PubMed Identifier
2439294
Citation
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.
Results Reference
background
PubMed Identifier
13457501
Citation
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.
Results Reference
background
PubMed Identifier
12614389
Citation
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.
Results Reference
background
PubMed Identifier
16266826
Citation
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.
Results Reference
background
PubMed Identifier
15985582
Citation
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.
Results Reference
background
Citation
The Psychological Corporation. Wechsler Test of Adult Reading. 2001, San Antonio, TX: Harcourt Assessment
Results Reference
background
Citation
Schwab RS. Research Publications. Reaction time in petit mal epilepsy. Association for Research in Nervous and Mental Disease 1947; 26:339-341.
Results Reference
background
Citation
Selldén U. Psychotechnical performance related to paroxysmal discharges in EEG. Clinical Electroencephalography 1971; 2:18-27.
Results Reference
background
PubMed Identifier
2450731
Citation
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.
Results Reference
background
PubMed Identifier
2450732
Citation
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.
Results Reference
background
Citation
Synder, P.J. Epilepsy. In Snyder, P.J. & Nussbaum, P.D, Clinical neuropsychology: a pocket handbook for assessment. 1998, Washington DC: American Psychological Association.
Results Reference
background
PubMed Identifier
11792161
Citation
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.
Results Reference
background
PubMed Identifier
12707428
Citation
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.
Results Reference
background
PubMed Identifier
14043044
Citation
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.
Results Reference
background
Citation
Tizard B, Margerison JH. Psychological functions during wave-spike discharge. British Journal of Social and Clinical Psychology 1963b; 3:6-15.
Results Reference
background
PubMed Identifier
12886976
Citation
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.
Results Reference
background

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Cognitive Effects of Treatment of Interictal Discharges

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