Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Disorders of Consciousness

NCT07694258 | Recruiting

• 1 other identifier: 6798
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorders of Consciousness; Disorders of Consciousness Due to Severe Brain Injury

Keywords

focused ultrasound; FUS; neuromodulation

Outcome Measures

Primary Outcomes (2)

• Feasibility of Bilateral Central Thalamic FUS Neuromodulation

  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.

  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 of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients with Disorders of Consciousness

  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.

  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.

Secondary Outcomes (6)

• Change in Behavioral Responsiveness (Coma Recovery Scale-Revised, CRS-R)

  Assessed at 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.

• Change in Glasgow Coma Scale (GCS)

  Assessed at 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.

• Change in Rancho Los Amigos Scale Level

  Assessed at 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.

• Change in EEG Measures of Neural Activity

  Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.

• Change in Resting-State Functional Connectivity (rs-fMRI)

  Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.

Study Arms (1)

Focused Ultrasound Neuromodulation

EXPERIMENTAL

Participants will receive two sessions of MRI-guided low-intensity focused ultrasound (FUS) neuromodulation using the FUS Next Generation Dome Helmet (NGDH), targeting the bilateral centromedian and parafascicular nuclei of the thalamus. Treatments will be spaced four weeks apart, plus or minus one week. All participants will receive the same intervention and will be followed for safety, feasibility, clinical outcomes, and neurophysiological effects, including follow-up through 12 weeks after the second treatment and additional assessments at 12 months post-injury when feasible.

Device: Next Generation Dome Helmet (NGDH)

Interventions

Next Generation Dome Helmet (NGDH) DEVICE

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.

Focused Ultrasound Neuromodulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Benjamin Davidson, MD, PhD

CONTACT

(416) 480-6100; benjamin.davidson@sunnybrook.ca

Jaana Leppala, Masters of Neuroscience

CONTACT

6476852284; jaana.leppala@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)