Infrared light therapy hat for adults with drug-resistant epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human trial gives all participants an investigational Red Light Therapy Hat to test safety, tolerability, and effects on seizure frequency. The device has shown seizure-reducing effects in animal models but has not been tested for epilepsy in people. Participants must be adults with drug-resistant epilepsy who keep an accurate seizure diary and have at least two seizures per month; key exclusions include intracranial stimulators, shunts, scalp cancer, or photosensitivity. Study visits take place at Beth Israel Deaconess Medical Center and will monitor seizure counts and device tolerability over the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Drug resistant epilepsy
* Age 18 or older
* Average seizure rate of at least 2 seizures per month
* Accurate seizure diary with at least 3 months recorded

Exclusion Criteria:

* Implanted intracranial neurostimulation device (DBS or RNS)
* Intracranial shunt
* Skin photosensitivity
* Cancer on scalp
* Taking any medication that can cause photosensitivity

Where it's running

• Bidmc
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Daniel Goldenholz, MD PhD — Beth Israel Deaconess Medical Center
• Study coordinator: Daniel Goldenholz, MD, PhD
• Email: daniel.goldenholz@bidmc.harvard.edu
• Phone: 617-632-8930

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Modified ketogenic diet for adults with drug-resistant epilepsy

  This study tests whether a modified ketogenic diet can help adults with drug-resistant epilepsy see fewer seizures and feel better overall.

  Recruiting Karolinska Institutet · Stockholm · NCT07878104

• Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

  This study tests whether low intensity focused ultrasound can help reduce seizures in adults with drug‑resistant epilepsy.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07680842

• iVEAcare Neuromodulation System for drug‑resistant epilepsy: a feasibility look

  This study tests whether the iVEAcare neuromodulation system is safe and can help reduce seizures and improve quality of life in people with drug‑resistant epilepsy.

  Recruiting at 7 sites iVEAcare · Herston, Queensland and 6 other locations · NCT07640191

• Real-world use of the OneRF Ablation System for epilepsy

  This registry collects real-world outcomes and device performance from patients with drug-resistant epilepsy who are treated with SEEG-guided RF ablation using the OneRF system.

  Recruiting at 3 sites NeuroOne Medical Technologies Corporation · Miami, Florida and 2 other locations · NCT07546253

• Overnight Temporal Interference Stimulation for Temporal Lobe Epilepsy

  This study tests whether overnight, non-invasive temporal interference stimulation to the hippocampus can reduce seizure-related brain activity and improve sleep in adults with drug-resistant temporal lobe epilepsy.

  Recruiting Duke University · Durham, North Carolina · NCT07434986

• Biomarkers of Response to SEEG Thermocoagulation

  This study tests biomarkers to see if they predict how well SEEG-guided radiofrequency thermocoagulation helps people with drug-resistant focal epilepsy.

  Recruiting Assistance Publique Hopitaux De Marseille · Marseille · NCT07399327

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.