Low Intensity Focused Ultrasound Treatment for Epilepsy: A Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and women's Hospital
RECRUITING
Boston
Contact Information
Primary
Ellen J Bubrick, MD
ebubrick@bwh.harvard.edu
617-732-7432
Backup
Lillian H Stapelfeld, BS
lstapelfeld@bwh.harvard.edu
8573071445
Time Frame
Start Date: 2019-02-07
Estimated Completion Date: 2026-03-09
Participants
Target number of participants: 10
Treatments
Experimental: Drug-Resistant Epilepsy (temporal lobe)
Pulsed low intensity focused ultrasound
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov