Trial · NCT00916149
Cognitive Effects of Treatment of Interictal Discharges
NCT00916149, Not applicable, Completed, Massachusetts General Hospital; results first posted 2018-08-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cognitive Effects of Treatment of Interictal Discharges. Trials, record NCT00916149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00916149
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cognitive Effects of Treatment of Interictal Discharges
- NCT number
- NCT00916149
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 31 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Epilepsy
- Interventions
- levetiracetam, Lamotrigine
- First posted
- 2009-06-09
- Last updated
- 2018-10-03
- Results first posted
- 2018-08-07
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment | 1 and 11 weeks | 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 | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score | 1 and 11 weeks | Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory) |
| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning | 1 and 11 weeks | 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. |
| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay | 1 and 11 weeks | Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled) |
| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay | 1 and 11 weeks | Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled) |
| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning | 1 and 11 weeks | 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) |
| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning | 1 and 11 weeks | 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) |
| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall | 1 and 11 weeks | 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) |
| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE | 1 and 11 weeks | Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life) |
| Secondary | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS | 1 and 11 weeks | 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 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment | 1 and 11 weeks | In a preliminary analysis, data from 11 healthy controls and 6 subjects with partial-onset epilepsy were evaluated. | IEDs/hour | MEAN |
| SECONDARY | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score | 1 and 11 weeks | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across measures. | scores on a scale | MEAN |
| SECONDARY | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning | 1 and 11 weeks | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | number recalled | MEAN |
| SECONDARY | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay | 1 and 11 weeks | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | number recalled | MEAN |
| SECONDARY | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay | 1 and 11 weeks | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | number recalled | MEAN |
| SECONDARY | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning | 1 and 11 weeks | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | number recalled | MEAN |
| SECONDARY | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning | 1 and 11 weeks | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | number recalled | MEAN |
| SECONDARY | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall | 1 and 11 weeks | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | number recalled | MEAN |
| SECONDARY | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE | 1 and 11 weeks | 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. | scores on a scale | MEAN |
| SECONDARY | Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS | 1 and 11 weeks | Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. | scores on a scale | MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment | No Treatment | -28.8 | Standard Deviation 71.8 | IEDs/hour | |
| Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment | Levetiracetam | .54 | Standard Deviation 1.44 | IEDs/hour | |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score | No Treatment | 2.45 | Standard Deviation 1.29 | scores on a scale | |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score | Levetiracetam | 2.5 | Standard Deviation 2.88 | scores on a scale | |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning | No Treatment | 8.09 | Standard Deviation 8.79 | number recalled | |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning | Levetiracetam | 5.5 | Standard Deviation 6.78 | number recalled | |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay | No Treatment | 1.27 | Standard Deviation 2.65 | number recalled | |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay | Levetiracetam | -0.4 | Standard Deviation 2.07 | number recalled | |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay | No Treatment | 1.55 | Standard Deviation 3.21 | number recalled | |
| Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay | Levetiracetam | 2.67 | Standard Deviation 2.16 | number recalled |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | No Treatment | 16 | |
| Overall Study | STARTED | Levetiracetam | 10 | |
| Overall Study | STARTED | Lamotrigine | 5 | |
| Overall Study | COMPLETED | No Treatment | 12 | |
| Overall Study | COMPLETED | Levetiracetam | 8 | |
| Overall Study | COMPLETED | Lamotrigine | 5 | |
| Overall Study | NOT COMPLETED | No Treatment | 4 | |
| Overall Study | NOT COMPLETED | Levetiracetam | 2 | |
| Overall Study | NOT COMPLETED | Lamotrigine | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Weight loss | General disorders | Levetiracetam | 0 | 8 | 0 |
| other | Weight loss | General disorders | Lamotrigine | 1 | 5 | 1 |
| other | Weight loss | General disorders | No Treatment | 0 | 12 | 0 |
| other | Frustration during cognitive testing | Psychiatric disorders | Levetiracetam | 0 | 8 | 0 |
| other | Frustration during cognitive testing | Psychiatric disorders | Lamotrigine | 0 | 5 | 0 |
| other | Frustration during cognitive testing | Psychiatric disorders | No Treatment | 1 | 12 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levetiracetam | 0 | 8 |
| Total, all-cause mortality | Lamotrigine | 0 | 5 |
| Total, all-cause mortality | No Treatment | 0 | 12 |
| Total, other adverse events | Levetiracetam | 0 | 8 |
| Total, other adverse events | Lamotrigine | 1 | 5 |
| Total, other adverse events | No Treatment | 1 | 12 |
| Total, serious adverse events | Levetiracetam | 0 | 8 |
| Total, serious adverse events | Lamotrigine | 0 | 5 |
| Total, serious adverse events | No Treatment | 0 | 12 |
Source ClinicalTrials.gov
Papers18
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Secondary outcome | ConductCognition |
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Design Fluency Test | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00916149
GET https://conductscience.org/api/trials/v1/NCT00916149/registered?page=2