A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

September 13, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Drug Resistant EpilepsyEpilepsy
Interventions
DEVICE

NaviFUS System

FUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: max. three consecutive 10-minute FUS exposures with two 5-minute intermission intervals.

Trial Locations (3)

22903

RECRUITING

University of Virginia School of Medicine, Charlottesville

94305

RECRUITING

Stanford University School of Medicine, Palo Alto

02115

RECRUITING

Brigham and Women's Hospital, Boston

Sponsors
All Listed Sponsors
collaborator

NaviFUS US LLC

UNKNOWN

lead

NaviFUS Corporation

INDUSTRY