NCT03868293 Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial
| NCT ID | NCT03868293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Drug Resistant Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2019-02-07 |
| Primary Completion | 2026-03-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2019-02-07 with a primary completion date of 2026-03-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the proposed pilot study is to investigate patient tolerability and efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy.
Eligibility 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.
Contact & Investigator
Ellen J Bubrick, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT03868293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drug Resistant Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03868293 currently recruiting?
Yes, NCT03868293 is actively recruiting participants. Contact the research team at ebubrick@bwh.harvard.edu for enrollment information.
Where is the NCT03868293 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03868293 clinical trial?
NCT03868293 is sponsored by Brigham and Women's Hospital. The principal investigator is Ellen J Bubrick, MD at Brigham and Women's Hospital. The trial plans to enroll 10 participants.
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