Could a zapping headband tame tough seizures?

NCT ID NCT04770337

Symptom relief Sponsor: Neuroelectrics Corporation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device that sends a very mild electrical current to the brain (tDCS) to see if it can safely reduce seizures in people with epilepsy that doesn't respond to medication. 127 participants aged 9 and older received either real or fake (sham) stimulation for 10 sessions over two weeks. Researchers tracked seizure changes and side effects for 10 more weeks to measure the treatment's effect on quality of life.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

127 people

The number who actually took part.

Started

Oct 2021

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 9 years old or older. 2. Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic-clonic seizures (International League Against Epilepsy classification). Diagnosis established by both clinical history and an EEG consistent with focal seizures. Note: A normal interictal EEG is consistent with focal seizures, if other data is adequate to provide localization. 3. Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure control despite demonstrated compliance, according to medical records, on at least two (2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's demographic according to package labeling, within approximately the last 3 years. 4. Seizure frequency average of ≥3 per month, over the past year. 5. Currently on at least 1 ASDs with no changes in antiepileptic drug doses in the 3 weeks prior to baseline visit in the study and no planned dose changes during the trial. Changes after baseline visit are permitted only if clinically necessary. 6. An MRI scan of the brain using a 1.5 Tesla magnet, or greater, with T1, T2 (recommended), and FLAIR sequences, acquired within the last 3 years for children (patients \<18 years old), or within 5 years for adult patients ≥18 years old, as long as the MRI was obtained after the onset of epilepsy and without brain surgeries after the MRI images. 7. Seizure focus that allows design of an appropriate stimulation montage. Note: Seizure focus can be identified within a lobe, or 2 adjacent lobes. Identification of the border of the seizure focus can be approximate (+/- 2 gyri). 8. Available seizure history and supporting data 9. All female study subjects of childbearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control (defined as having a documented failure rate of \<=1%; for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as effective). 10. Written informed consent obtained from study patient or patient's legal representative and ability for study patient to comply with the requirements of the study. 11. Assent from pediatric patients when appropriate. Exclusion Criteria: 1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the integrity of the data. 2. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is defined as a cortical region confined to one hemisphere and either one lobe or on a junction of two adjacent lobes from which seizures arise, as documented by scalp or intracranial EEG, that is either supported or not refuted by MRI, and either supported or not refuted by clinical semiology). If the interictal EEG is normal, a seizure focus may be identified by the combination of structural findings on MRI and clinical signs/symptoms associated with the patient's seizures. 3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal 4. Seizure focus is hemispheric or poorly defined 5. History of psychogenic non-epileptic seizures in past 2 years, or physiologic nonepileptic seizures and non-epileptogenic events, including suspicion for or a significant history of syncope, and any non-epileptic events must be clearly differentiable from patient's focal seizures based on previously recorded video EEG showing distinct clinical and electrographic features of the patient's psychogenic non-epileptic seizures (PNES) compared to their epileptic seizures. 6. Seizures of generalized onset 7. Status epilepticus in the last 12 months 8. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise interfere, limit, affect or reduce the patient's ability to complete a study duration of 28 weeks (4 weeks screening, 12 weeks baseline, 2 weeks tDCS, 10 weeks follow-up). 9. Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may adversely impact the safety of the patient or the integrity of the data. 10. Damaged skin on scalp that may interfere with tDCS stimulation. 11. Pregnant or unwilling to practice birth control during participation in the study. 12. Nursing mothers. 13. Any cranial metal implants (excluding ≦1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e., cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant). Note: Vagus nerve stimulator (VNS) is allowable if the device is in MR Mode (e.g., switched off) during tDCS stimulation and the VNS device is MR conditional. 14. Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm. 15. Substance use disorder (including alcohol) according to Diagnostic and Statistical Manual, 5th edition (DSM-V) criteria in the past 3 years. 16. Participation in an interventional clinical trial within 30 days prior to screening. 17. Patient's head circumference \> 64 cm

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Conditions

The condition(s) this trial relates to.

childhood-onset epilepsy syndrome Drug Resistant Epilepsy epilepsy epilepsy with generalized tonic-clonic seizures focal epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy Epilepsy in children Epilepsy, tonic-clonic Focal seizure Refractory epilepsy Seizures Seizures, focal

Contacts and locations

Locations

Barrow Neurological Institute, St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States
Beth Israel Deconess Medical Center

Boston, Massachusetts, 02215, United States
Boston Children's Hospital Comprehensive Epilepsy Center

Boston, Massachusetts, 02115, United States
CHU de Marseille - Hôpital de la Timone

Marseille, France
Centro de Neurología Avanzada

Seville, Spain
Children's Hospital of Orange County

Orange, California, 92868, United States
Cliniques Universitaires Saint Luc

Brussels, Belgium
Ghent University Hospital

Ghent, Belgium
HM Nou Delfos

Barcelona, Spain
Hospices Civils De Lyon

Lyon, France
Hospital Clínic

Barcelona, Spain
Hospital Del Mar

Barcelona, Spain
Hospital Niño Jesús

Madrid, Spain
Hospital Ruber Internacional

Madrid, Spain
Hospital Sant Joan de Déu

Barcelona, Spain
Hospital Universitari Vall d'Hebron

Barcelona, Spain
Hospital Universitario Albacete

Albacete, Spain
Hospital Universitario Regional de Málaga

Málaga, Spain
Johns Hopkins University

Baltimore, Maryland, 21287, United States
Keck Medicine of USC

Los Angeles, California, 90033, United States
Loma Linda University Health

Loma Linda, California, 92354, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Robert Wood Johnson Medical School (Rutgers)

New Brunswick, New Jersey, 08901, United States
Seattle Children's Hospital, University of Washington

Seattle, Washington, 98105, United States
Sinai Hospital

Baltimore, Maryland, 21215, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
University Of Utah

Salt Lake City, Utah, 84132, United States
University of Florida Jacksonville

Jacksonville, Florida, 32209, United States
University of Pennsylvania (Penn Epilepsy)

Philadelphia, Pennsylvania, 19104, United States
University of Rochester

Rochester, New York, 14642, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States
Washington University Medical Center

St Louis, Missouri, 63110, United States

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