Clinical Trial

Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Disorders of Consciousness

Recruiting
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Summary
The main questions this study aims to answer are: Can low-intensity FUS neuromodulation be safely and feasibly administered to the bilateral central thalamus in patients with disorders of consciousness (DoC)? Does FUS neuromodulation result in short-term improvements in arousal or behavioral responsiveness? Does FUS neuromodulation produce measurable changes in neural activity on EEG and/or fMRI? Participants will: Receive two sessions of low-intensity FUS neuromodulation, spaced four weeks apart, plus or minus one week. Undergo pre- and post-treatment assessments, including planning CT, MRI/fMRI, EEG, and standardized clinical scales such as the Coma Recovery Scale-Revised (CRS-R) and Glasgow Coma Scale (GCS). Be continuously monitored for safety during and after each FUS treatment. Complete follow-up imaging and clinical assessments approximately 2 weeks after each FUS session, 12 weeks after the second treatment, and at 12 months post-injury when clinically feasible.
Trial Details
NCT Number NCT07694258
Lead Sponsor Sunnybrook Health Sciences Centre
Conditions Disorders of Consciousness Due to Severe Brain Injury, Disorders of Consciousness
Enrollment 10 participants
Start Date 2025-09-10
Primary Completion 2027-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-09