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insufficient study staff
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The purpose of this investigation is data pilot study of the effect of theta frequency stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy. We will compare the effects of no stimulation, theta frequency (5 Hz), and 'standard' beta frequency stimulation (25-30 Hz) on cognitive measures. We hypothesize that theta frequency VNS will have a positive effect on memory retention. The goal of this study to provide initial data to inform the design of a larger clinical trial to examine the efficacy of theta VNS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No stimulation | Experimental | All patients will receive three different stimulations |
|
| Beta (25-30 Hz) | Other | Vagal nerve stimulator will be set to Beta (25-30 Hz) |
|
| Theta (5 Hz) | Other | Vagal nerve stimulator will be set to Theta (5 Hz) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no stimulation | Other | Vagal nerve stimulator will be set to no stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| California Verbal and Learning Test 2nd edition group 1 | Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16 | hour 1.5 |
| California Verbal and Learning Test 2nd edition group 2 | Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16 | hour 2.25 |
| California Verbal and Learning Test 2nd edition group 3 | Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16 | hour 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Pilot Study
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| beta (25-30 Hz) |
| Other |
Vagal nerve stimulator will be set to beta (25-30 Hz) |
|
| Theta (5 Hz) | Other | Vagal nerve stimulator will be set to beta (5 Hz) |
|