Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Disorders of Consciousness
Sunnybrook Health Sciences Centre
10 participants
Sep 10, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria5
- 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
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Interventions
Participants will receive MR-guided focused ultrasound neuromodulation using the Next Generation Dome Helmet (NGDH). Each participant will undergo two treatment sessions spaced four weeks apart. MRI and CT imaging will be used to guide targeting of the bilateral centromedian/parafascicular nuclei of the thalamus. Continuous monitoring will be performed during each session, and follow-up clinical, EEG, and MRI assessments will be conducted to evaluate safety, feasibility, and preliminary effects.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07694258