Recruiting

LIFU

Sponsor:

UCLA

Code:

NCT07680842

Conditions

Drug-Resistant Epilepsy

Epilepsy

Epilepsy (Treatment Refractory)

Epilepsy Comorbidities

Epilepsy, Drug Resistant

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Target optimization using LIFU

Serial LIFU stimulation

Study Details

Brief 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.

Conditions

Drug-Resistant Epilepsy

Epilepsy

Epilepsy (Treatment Refractory)

Epilepsy Comorbidities

Epilepsy, Drug Resistant

Study ID

NCT07680842

Start date

Jul 9, 2025

Status verified date

Jun, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Target optimization using LIFU

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

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.

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 and Locations

Central contacts

Study Coordinator

4155087069lifu.research@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94107

Principal Investigator:

Joline M Fan, MD, MS

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Seizures
  • Drug-Resistant Epilepsy
  • Epilepsy
  • Transcranial Ultrasound Stimulation
  • Focused ultrasound Stimulation
  • Electroencephalography (EEG)
  • Low Intensity Focused ultrasound (LIFU)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-02.