Using focused ultrasound to treat 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 pilot study aims to evaluate the safety and tolerability of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients suffering from drug-resistant temporal lobe epilepsy. Participants will undergo six treatment sessions over three weeks, with each session lasting 1-2 hours. The study will also involve tracking seizure events through a Daily Seizure Log Diary for six months. The goal is to explore a non-invasive treatment option for patients who have not responded to traditional medications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects at least eighteen (18) years of age
* Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and/or EEG findings.
* Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency
* Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments.

Exclusion Criteria:

* Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing
* Subjects with dementia or other progressive degenerative disease, delirium or active psychosis
* Subjects with ferromagnetic materials in the head
* Subjects with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit
* Subjects who have primary generalized epilepsy or non-epileptic seizures
* Subjects who have experienced status epilepticus in the 3 months leading up to enrollment in the study
* Subjects (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period.
* Subjects who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still)
* Subjects with current brain tumors or an intracranial vascular lesion
* Subjects with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.
* Subjects with holes in the treatment area of the skull from trauma or prior surgery
* Subjects with pacemakers, medication pumps, and other implanted electronic hardware. If a subject has a working Vagal Nerve Stimulator in place, the device will be turned off prior to each treatment session and then turned back on after each session.

Where it's running

• Brigham and women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Ellen J Bubrick, MD — Brigham and Women's Hospital
• Study coordinator: Ellen J Bubrick, MD
• Email: ebubrick@bwh.harvard.edu
• Phone: 617-732-7432

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.