Innovative Repurposing of Trigeminal Nerve Stimulation of the Treatment of Epilepsy in Veterans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Baylor College of Medicine
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Seizure frequency
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
There are no parties who are masked.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults age 18 to 65 years of age at time of consent
- •Subject must have a confirmed diagnosis of epilepsy of at least 1 year, specified as focal onset epilepsy.
- •Focal epilepsy with motor signs
- •A minimum seizure frequency of one seizure over a 4-week period
- •Subject must have failed to achieve seizure control with at least two appropriate antiseizure medications (ASM) based on the 2009 ILAE definition of drug resistant epilepsy
- •Current treatment with at least 1 ASM with stable doses for at least three months
Exclusion Criteria
- •Any condition that would impact a subject's ability to follow study procedures or subject's safety
- •History of significant adverse reactions to electrical stimulation (e.g. TEMS device)
- •Subjects with only focal aware nonmotor seizures
- •Women of childbearing age, pregnant or breastfeeding
- •Implanted cardiac pacemaker or implanted/wearable defibrillator or implanted metallic device in head
Outcomes
Primary Outcomes
Seizure frequency
Time Frame: 6 months
The primary outcome will be the reduction in seizure frequency with the treatment device compared to baseline measurements.
Secondary Outcomes
- Beck Depression Inventory(6 months)
- QOLIE-31(6 months)
Investigators
Hina Dave
Principal Investigator
Baylor College of Medicine