Actively Recruiting
Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial
Led by Brigham and Women's Hospital · Updated on 2025-09-17
10
Participants Needed
1
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects at least eighteen (18) years of age
- Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness and who have failed at least two trials of antiepileptic drugs
- Subjects who experience at least 1-2 seizures per month on average and can reliably log seizure frequency
- Subjects who have the cognitive ability to read and understand the consent form and describe any symptoms during or after treatments
You will not qualify if you...
- Subjects with cognitive or psychiatric disorders limiting informed consent or cooperation with testing
- Subjects with dementia, 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 with primary generalized epilepsy or non-epileptic seizures
- Subjects who experienced status epilepticus within 3 months before enrollment
- Pregnant females or females of childbearing potential not willing to use reliable birth control during treatment
- Subjects unable to undergo brain MRI for any reason
- Subjects with current brain tumors or intracranial vascular lesions
- Subjects with severe uncontrolled medical conditions such as diabetes, hypertension, pulmonary disease, heart failure, or coronary artery disease
- Subjects with holes in skull treatment area from trauma or surgery
- Subjects with pacemakers, medication pumps, or other implanted electronic hardware (Vagal Nerve Stimulator users will have device turned off during treatments)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
E
Ellen J Bubrick, MD
CONTACT
L
Lillian H Stapelfeld, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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