Disorders of Consciousness Due to Severe Brain InjuryDisorders of Consciousness
Investigational drug(s) / intervention(s)
Next Generation Dome Helmet (NGDH)
Next Generation Dome Helmet (NGDH): 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.
Study 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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Feasibility of Bilateral Central Thalamic FUS Neuromodulation — Assessed at Screening/Baseline, Treatment 1, Mid-treatment assessment (2 weeks after Treatment 1), Treatment 2 (4 weeks after Treatment 1), 2-week follow-up (2 weeks after each treatment), 12 weeks after Treatment 2, and 1-year follow-up. Feasibility will be defined as the proportion of enrolled participants who complete both focused ultrasound (FUS) neuromodulation sessions without protocol deviation or occurrence of a serious adverse event (SAE) related to the procedure.
Safety of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients with Disorders of Consciousness — Assessed at Screening/Baseline, Treatment 1, Mid-treatment assessment (2 weeks after Treatment 1), Treatment 2 (4 weeks after Treatment 1), 2-week follow-up (2 weeks after each treatment), 12 weeks after Treatment 2, and 1-year follow-up. Safety will be assessed by the frequency, type, and severity of adverse events (AEs) and serious adverse events (SAEs) following FUS treatment. Events of interest include seizures, autonomic instability, new focal neurological deficits, clinical deterioration, or structural abnormalities detected on post-treatment MRI.
Trial sites (1)
Facility
City
Region
Status
Sunnybrook Health Sciences Centre
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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