Recruiting

Low Intensity Focused Ultrasound

Sponsor:

Brigham and Women's Hospital

Code:

NCT03868293

Conditions

Drug Resistant Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Focused ultrasound

Study Details

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

Study ID

NCT03868293

Start date

Feb 7, 2019

Status verified date

Jun, 2026

Completion date

Mar 9, 2027

Anticipated

Primary completion date

Mar 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Drug-Resistant Epilepsy (temporal lobe)

Pulsed low intensity focused ultrasound

Interventions

Focused ultrasound

Pulsed low intensity focused ultrasound

Primary outcome measure

  • Patient tolerability of moderate term, repeated exposure toPulsed Low-Intensity Focused Ultrasound (PLIFUS) (Adverse Events assessment) [ Time Frame: 3 months ]
  • Efficacy of PLIFUS in reducing seizure frequency [ Time Frame: 3 months ]
  • Effect of PLIFUS on patient EEG (evaluate number of attenuated epileptiform discharges) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Ellen J Bubrick, MD

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

Lillian H Stapelfeld, BS

8573071445lstapelfeld@bwh.harvard.edu

Locations

Brigham and women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ellen J Bubrick, MD

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

Lillian H Stapelfeld, BS

8573071445lstapelfeld@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-06-18.