Epilepsy (Treatment Refractory)NCT07220161
Trigeminal Nerve Stimulation of the Treatment of Epilepsy
A study testing Trigeminal nerve stimulation in people with Epilepsy (Treatment Refractory), run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Epilepsy (Treatment Refractory)
- What is being tested?
- Trigeminal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Repurposing of Trigeminal Nerve Stimulation of the Treatment of Epilepsy in Veterans
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.
- Conditions
- Epilepsy (Treatment Refractory)
- Being tested
- Trigeminal nerve stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigeminal nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Trigeminal Nerve Stimulation | Experimental | Treatment with trigeminal nerve stimulation x 6 months Receives: Device: Trigeminal nerve stimulation |
| Control | No intervention | Standard care x 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
The primary outcome will be the reduction in seizure frequency with the treatment device compared to baseline measurements.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Beck Depression Inventory
Mood will be followed with the Beck Depression Inventory.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start8 May 2025
- Primary completion8 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy (Treatment Refractory)Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Cefaly Connected
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Michael E. DeBakey VA Medical Center
- Responsible party
- Principal investigator, Hina Dave, Baylor College of Medicine
- Investigators
- Hina Dave, MD, Principal investigator, Baylor College of Medicine/Debakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220161
- Sponsor's protocol ID
- H-55827
- Status last verified
- Oct 2025
- First submitted
- 21 Oct 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24289825
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Repurposing of Trigeminal Nerve Stimulation of the Treatment of Epilepsy in Veterans
- ClinicalTrials.gov ID
- NCT07220161
- Acronym / sponsor ID
- H-55827
- Conditions
- Epilepsy (Treatment Refractory)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Michael E. DeBakey VA Medical Center
- Study start
- 8 May 2025 (actual)
- Primary completion
- 8 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cefaly Connected
| Arm | Type | Receives |
|---|---|---|
| Treatment with Trigeminal Nerve Stimulation | Experimental | Device: Trigeminal nerve stimulationTreatment with trigeminal nerve stimulation x 6 months |
| Control | No intervention | –Standard care x 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigeminal nerve stimulationThe 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. | Device | Treatment with Trigeminal Nerve Stimulation |
Primary outcome
Seizure frequency
Time frame: 6 months
The primary outcome will be the reduction in seizure frequency with the treatment device compared to baseline measurements.
2 secondary outcomes
QOLIE-31
Time frame: 6 months
Beck Depression Inventory
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Background: PubMed 24289825Magis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hina Dave, MD principal investigator
Baylor College of Medicine/Debakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigeminal nerve stimulation in people with Epilepsy (Treatment Refractory), run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07220161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.