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| Name | Class |
|---|---|
| Michael E. DeBakey VA Medical Center | FED |
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Background: Epilepsy is a common neurological disorder among veterans. Medications do not control seizures in 1/3rd of patients, who often require neurostimulation. However, current neurostimulation devices are invasive. Objective: The investigators propose a novel clinical trial to repurpose the FDA-approved Cefaly device, designed for migraine relief, to treat epilepsy. The Cefaly device works by non-invasive Trigeminal neurostimulation (TNS). TNS has previously shown promising preliminary results in seizure improvement. Design: The investigators will engage 24 veterans with drug-resistant epilepsy, half of whom will receive standard care, while the other half will receive standard care plus Cefaly. This will be followed by a crossover of the treatment/control groups. The primary objective is to evaluate seizure frequency improvement over 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Trigeminal Nerve Stimulation | Experimental | Treatment with trigeminal nerve stimulation x 6 months |
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| Control | No Intervention | Standard care x 6 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigeminal nerve stimulation | Device | The study device, "Cefaly® Connected", is a non-invasive neuromodulation tool designed for the prevention and treatment of migraine headaches. It works by delivering transcutaneous electrical stimulation to the bilateral supraorbital nerves, which are branches of the trigeminal nerve. The device is placed on the forehead, and it emits electrical impulses that modulate the activity of the trigeminal nerve. |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure frequency | The primary outcome will be the reduction in seizure frequency with the treatment device compared to baseline measurements. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| QOLIE-31 | Improvement in quality of life as a secondary outcome with a focus on daily functionality, mental health, and overall subject well-being. This will be collected through the QOLIE-31. | 6 months |
| Beck Depression Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hina Dave, MD | Baylor College of Medicine/Debakey VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Debakey VA Medical Center | Houston | Texas | 77080 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24289825 | Background | Magis D, Sava S, d'Elia TS, Baschi R, Schoenen J. Safety and patients' satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly(R) device in headache treatment: a survey of 2,313 headache sufferers in the general population. J Headache Pain. 2013 Dec 1;14(1):95. doi: 10.1186/1129-2377-14-95. |
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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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Cefaly Connected
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There are no parties who are masked.
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Mood will be followed with the Beck Depression Inventory.
| 6 months |