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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
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Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Vagus nerve stimulation paradigm #1 |
|
| 2 | Experimental | Vagus nerve stimulation paradigm #2 |
|
| 3 | Experimental | Vagus nerve stimulation paradigm #3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus nerve stimulation paradigm #1 | Procedure | Vagus nerve stimulation parameters #1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type | After 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| VNS-related side effects | After 6 and 12 months | |
| Battery life | After 6 and 12 months | |
| Quality of life: changes in QOLIE 89 score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Boon, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Vijay Thadani, MD | Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | |||
| University Hospital Ghent |
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| Label | URL |
|---|---|
| Website of the University Hospital Ghent | View source |
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| Vagus nerve stimulation paradigm #2 |
| Procedure |
Vagus nerve stimulation parameters #2 |
|
| Vagus nerve stimulation paradigm #3 | Procedure | Vagus nerve stimulation parameters #3 |
|
| After 12 months |
| Mood assessment: changes in Beck depression scale scores | After 12 months |
| Ghent |
| 9000 |
| Belgium |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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