Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy
Purpose
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.
Conditions
- Drug-Resistant Epilepsy
- Epilepsy
- Epilepsy (Treatment Refractory)
- Epilepsy Comorbidities
- Epilepsy, Drug Resistant
- Epilepsy, Generalized
- Epilepsy, Focal
Eligibility
- Eligible Ages
- Between 21 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- Has a craniotomy or pathologic intracranial lesion (e.g. vascular malformations) in the trajectory of the focused ultrasound beam. - Pregnant, breastfeeding, is attempting pregnancy, or unwilling to practice birth control during participation in the study. - Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. - Has any unstable medical or psychiatric disease. - Any contraindications for completing a brain MRI scan. - Has evidence of any other clinically relevant neurological disorder at the time of screening, including Alzheimer's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, and multiple sclerosis.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Participants in this single experimental group will undergo a series of low-intensity focused ultrasound (LIFU) sessions to evaluate safety, tolerability, and preliminary efficacy. The study utilizes a within-subject, sham-controlled design where participants receive both active LIFU and sham (placebo) stimulation across different sessions to compare clinical response. Active LIFU stimulation sessions will assess up to three targets relevant to the epileptogenic network. If an optimal target is identified, patients will then undergo serial stimulation of the optimal target.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
University of California, San Francisco
San Francisco, California 94107
San Francisco, California 94107
More Details
- Status
- Recruiting
- Sponsor
- University of California, San Francisco