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Study identifier: NCT07694258 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Disorders of Consciousness Due to Severe Brain Injury · Disorders of Consciousness  ·  Sponsor: Sunnybrook Health Sciences Centre

PhaseNA
Planned participants10
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Benjamin Davidson, MD, PhD  ·  (416) 480-6100  ·  benjamin.davidson@sunnybrook.ca

Jaana Leppala, Masters of Neuroscience  ·  6476852284  ·  jaana.leppala@sunnybrook.ca

Always discuss trial participation with your own doctor first.

Locations (1)

Sunnybrook Health Sciences CentreToronto, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT07694258