Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Disorders of Consciousness
Recruiting
N/A
Interventional Study
Disorders of Consciousness Due to Severe Brain Injury
Disorders of Consciousness
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- Sunnybrook Health Sciences Centre · Other
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About This Trial
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?…
Trial Locations
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Eligibility Criteria
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…
Contacts