Epilepsy (Treatment Refractory)
Conditions
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.
Interventions
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.
Sponsors
Michael E. DeBakey VA Medical Center
Baylor College of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
There are no parties who are masked.
Intervention model description
Cefaly Connected
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure frequency | 6 months | The primary outcome will be the reduction in seizure frequency with the treatment device compared to baseline measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QOLIE-31 | 6 months | 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. |
| Beck Depression Inventory | 6 months | Mood will be followed with the Beck Depression Inventory. |
Countries
United States
Outcome results
None listed