Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial

NCT ID: NCT03868293

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-07
• Study Completion Date: 2026-03-09

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.

Detailed Description

The aim of the proposed pilot study is to investigate safety and tolerability of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy.

Due to the lack of options for patients with drug-resistant epilepsy, investigations into alternative noninvasive treatments are warranted. PLIFUS has been shown to safely modulate neuronal tissue, and is non-invasive and painless. Several human studies have shown that the use of PLIFUS can suppress somatosensory evoked potentials and induce functional magnetic resonance imaging (MRI) responses.

Once the subject is enrolled in the study, the subject will be scheduled for a standard brain MRI scan at BWH if they have not had one in the last 3 months. The subject will be asked to keep track of their seizure events in the Daily Seizure Log Diary from the screening visit until 6 months after the last treatment session.

The treatment period will include 6 treatment sessions total. These will occur 2 days per week for 3 weeks, each lasting approximately 1-2 hours, starting 1 month after seizure logging begins.

Conditions

Drug Resistant Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Drug-Resistant Epilepsy (temporal lobe)

Pulsed low intensity focused ultrasound

Group Type: EXPERIMENTAL

Focused ultrasound

Intervention Type: DEVICE

Pulsed low intensity focused ultrasound

Interventions

Focused ultrasound

Pulsed low intensity focused ultrasound

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ellen J Bubrick

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen J Bubrick, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ellen J Bubrick, MD

Role: CONTACT

ebubrick@bwh.harvard.edu

617-732-7432

Lillian H Stapelfeld, BS

Role: CONTACT

lstapelfeld@bwh.harvard.edu

8573071445

Facility Contacts

Ellen J Bubrick, MD

Role: primary

ebubrick@bwh.harvard.edu

617-732-7432

Lillian H Stapelfeld, BS

Role: backup

lstapelfeld@bwh.harvard.edu

8573071445

References

Bubrick EJ, McDannold NJ, White PJ. Low Intensity Focused Ultrasound for Epilepsy- A New Approach to Neuromodulation. Epilepsy Curr. 2022 Mar 29;22(3):156-160. doi: 10.1177/15357597221086111. eCollection 2022 Jun.

Reference Type: BACKGROUND

PMID: 36474831 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018P000125

Identifier Type: -

Identifier Source: org_study_id