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Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy

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

The goal of this study is to investigate the effects of a non-invasive, low intensity focused ultrasound (LIFU) stimulation on seizure frequency and the epileptogenic network in drug-resistant epilepsy. LIFU uses focused sound waves to modulate deep brain regions and to enable changes in brain network activity. Encephalography (EEG) and behavioral tasks will also be used to study how LIFU affects brain activity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
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• Male or female between 21 and 65 years of age at screening

• Clinical diagnosis of drug-resistant epilepsy with on average, 4 or more seizures per month.

• Able to provide informed consent (or assent when applicable) by the subject or subject's legal representative.

• Be willing to undergo a brain MRI.

• Be able and willing to wear a headband during the treatment duration.

• Be able to complete scheduled visits and daily seizure logs.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Study Coordinator
lifu.research@ucsf.edu
4155087069
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 40
Treatments
Active_comparator: Target optimization using LIFU
Participants in this single experimental group will undergo a series of LIFU sessions to determine optimal clinical response. Each participant will receive active LIFU stimulation of up to three personalized brain targets. The study utilizes a within-subject, sham-controlled design where participants receive both active LIFU and sham (placebo) stimulation across different sessions to compare physiological and clinical responses.
Active_comparator: Serial LIFU stimulation
If an optimal target is identified, patients will undergo serial stimulation of the optimal target.
Related Therapeutic Areas
Seizures
Epilepsy
Sponsors
Leads: University of California, San Francisco
Collaborators: Attune Neurosciences Inc

This content was sourced from clinicaltrials.gov

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