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Pilot Study: Focused Ultrasound for Drug-Resistant Epilepsy

This pilot study is looking at a new treatment called Pulsed Low-Intensity Focused Ultrasound (PLIFUS) for people with temporal lobe epilepsy that hasn't responded to other medications (drug-resistant epilepsy). Researchers want to see if PLIFUS is safe and if it can help reduce how often seizures happen. They will also check how PLIFUS affects brain activity using an EEG (a test that measures electrical activity in the brain). You might be able to join if you are at least 18 years old and have drug-resistant temporal lobe epilepsy. The study plans to enroll 10 participants, but the current recruitment status is unclear.

Study design
This is an interventional pilot study with a planned enrollment of 10 participants.
What's involved
You will have 6 treatment sessions over 3 weeks, each lasting 1-2 hours. You will also need a brain MRI scan and will keep a daily seizure log for several months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 3 months after treatment to assess tolerability, seizure frequency, and EEG changes.

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NCT03868293

Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial

Recruiting
NAAges 18+Interventional
Brigham and Women's Hospital
~10 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Focused ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient tolerability of moderate term, repeated exposure toPulsed Low-Intensity Focused Ultrasound (PLIFUS) (Adverse Events assessment)
Measured over 3 months
+2 more outcomes measured

Conditions

Drug Resistant Epilepsy

Explore related trials

Temporal Lobe Epilepsy

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Ellen J Bubrick, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Ellen J Bubrick, MD
[email protected]
617-732-7432
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Patient tolerability of moderate term, repeated exposure toPulsed Low-Intensity Focused Ultrasound (PLIFUS) (Adverse Events assessment)3 months

    The aim of the proposed pilot study is to investigate patient tolerability of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy. We hypothesize that the treatments will be well-tolerated, without adverse events.

  • Efficacy of PLIFUS in reducing seizure frequency3 months

    The aim of the proposed pilot study is to investigate patient efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy .We hypothesize that PLIFUS stimulation will result in mechanical disruption of the target tissue (here, the epileptogenic focus), preserving the integrity of the tissue but rendering it unable (or less able) to mount seizure activity for a period of time. We, therefore, will assess improvement in subjects' seizure frequency by evaluating seizure frequency during and 30 days after the treatment period relative to a 30 day pre-treatment baseline period.

  • Effect of PLIFUS on patient EEG (evaluate number of attenuated epileptiform discharges)3 months

    We hypothesize that subjects' EEGs will show improvement (fewer and/or attenuated epileptiform discharges). Study Epileptologists (either the PI or Co-I) will interpret EEG results during the first and last treatment session.