Focusing ultrasound to the central thalamus to help people with disorders of consciousness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small, single-center pilot study that will apply two sessions of low-intensity FUS neuromodulation to the bilateral central thalamus, about four weeks apart, in people with disorders of consciousness. Participants will have extensive safety monitoring and undergo imaging, EEG, and standardized scales before and after treatment to look for short-term changes in arousal and brain activity. The study also collects follow-up data up to 12 months when feasible to assess longer-term effects. The approach uses the Next Generation Dome Helmet to deliver targeted ultrasound while patients are monitored for safety. Results will inform feasibility, safety, and potential signals of clinical or neurophysiological change.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of severe traumatic brain injury, hypoxic-ischemic brain injury, or other acute brain injury.
2. Glasgow coma scale below 13 when off sedation, or on minimal sedation.
3. Absence of another better explanation for the depressed level of consciousness (e.g,, metabolic abnormality, seizures)
4. 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).
5. 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.

Exclusion Criteria:

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

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Benjamin Davidson, MD, PhD
• Email: benjamin.davidson@sunnybrook.ca
• Phone: (416) 480-6100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.