RecruitingNot ApplicableNCT07680842

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

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

Sponsor

University of California, San Francisco

Enrollment

40 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Serial LIFU stimulation and a medical device called Target optimization using LIFU for people with drug resistant epilepsy, epilepsy, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETarget 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.

DEVICESerial 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.