MedTrace Logo

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

NCT07680842 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-02

No results posted yet for this study

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
  • Epilepsy, Generalized
  • Epilepsy, Focal

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

Principal Investigators

  • Joline M Fan, MD, MS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2027-06-01
Completion
2027-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07680842 on ClinicalTrials.gov