Using focused ultrasound to treat drug-resistant epilepsy
Low Intensity Focused Ultrasound Treatment for Epilepsy: A Pilot Trial
This study is testing a new ultrasound treatment for people with drug-resistant epilepsy to see if it can help reduce their seizures without using medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03868293 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with drug-resistant temporal lobe epilepsy who experience 1-2 seizures per month.
Not a fit: Patients with cognitive or psychiatric disorders that impair informed consent or those with ferromagnetic materials in the head may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option for patients with drug-resistant epilepsy.
How similar studies have performed: While focused ultrasound is a novel approach in this context, previous studies have shown its potential in modulating neuronal tissue safely.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.