Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial

NCT03868293 | Recruiting FDA Device

• 1 other identifier: 2018P000125
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Resistant Epilepsy

Outcome Measures

Primary Outcomes (3)

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

  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.

  3 months

• Efficacy of PLIFUS in reducing seizure frequency

  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.

  3 months

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

  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.

  3 months

Study Arms (1)

Drug-Resistant Epilepsy (temporal lobe)

EXPERIMENTAL

Pulsed low intensity focused ultrasound

Device: Focused ultrasound

Interventions

Focused ultrasound DEVICE

Pulsed low intensity focused ultrasound

Drug-Resistant Epilepsy (temporal lobe)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36474831 BACKGROUND

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ellen J Bubrick, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen J Bubrick, MD

CONTACT

617-732-7432; ebubrick@bwh.harvard.edu

Lillian H Stapelfeld, BS

CONTACT

8573071445; lstapelfeld@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: March 11, 2019
• Study Start: February 7, 2019
• Primary Completion: March 9, 2026
• Study Completion: March 9, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)