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

Recruiting now · Not applicable

Conditions studied: Disorders of Consciousness Due to Severe Brain Injury, Disorders of Consciousness

In brief

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.

Key facts

Study ID

NCT07694258

Run by

Sunnybrook Health Sciences Centre

People needed

10

Starts

2025-09-10

Expected to finish

2028-09-01

Last updated by the study team

2026-07-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of severe traumatic brain injury, hypoxic-ischemic brain injury, or other acute brain injury.
• Glasgow coma scale below 13 when off sedation, or on minimal sedation.
• Absence of another better explanation for the depressed level of consciousness (e.g,, metabolic abnormality, seizures)
• Intracranial pressure (ICP) is within a normal range (< 20 cm H2O), or, a neurosurgeon associated with the study and/or the treating physician agree that ICP is likely < 20 cm H2O based on clinical and neuroimaging information (acknowledging the limitations of non-invasive assessment of ICP53).
• The treating physician and/or neurosurgeon associated with the study evaluate it to be safe for the patient to be transported to the MRI scanner for a \~45 minute scan.

You may not qualify if…

• Active seizure activity or post-anoxic myoclonus at the time of proposed treatment
• Taking full anti-coagulation medication (does not include deep-vein-thrombosis chemoprophylaxis)
• Skull anatomy incompatible with safe FUS delivery (as determined by CT)
• Medical instability that would preclude safe transport or prolonged supine positioning
• Presence of any MRI-incompatible implants or devices

Where it is running

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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