NCT07694258 Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Disorders of Consciousness
| NCT ID | NCT07694258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Disorders of Consciousness Due to Severe Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-09-10 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07694258 clinical trial?
This trial is open to participants of all sexes, studying Disorders of Consciousness Due to Severe Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07694258 currently recruiting?
Yes, NCT07694258 is actively recruiting participants. Contact the research team at benjamin.davidson@sunnybrook.ca for enrollment information.
Where is the NCT07694258 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07694258 clinical trial?
NCT07694258 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 10 participants.