Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07680842
Status
Recruiting
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Conditions

  • Drug-Resistant Epilepsy
  • Epilepsy
  • Epilepsy (Treatment Refractory)
  • Epilepsy Comorbidities
  • Epilepsy, Drug Resistant
  • Epilepsy, Focal
  • Epilepsy, Generalized

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Target optimization using LIFU — DEVICE
    LIFU will be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Positioning is guided by an offline MRI scan, enabling non-invasive targeting of the LIFU beams directly to deep brain structures. Targeting will be determined based on the epileptogenic network.
  • Serial LIFU stimulation — DEVICE
    Serial LIFU will again be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Serial stimulation target selection will be based on the initial target optimization outcome, including the assessment of physiology and clinical treatment response.

Study Details

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.

Key Dates

Start date
Jul 9, 2025
Status verified
Jun 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Seizure Frequency [ Time Frame: Seizure counts will be obtained daily for at least 1 month prior to the first study visit, throughout the study which averages around 4 months, and monitored for up to 2 months after the final visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94107
Joline M Fan, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
University of California, San Francisco· San Francisco, CA

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