Recruiting

FUS Neuromodulation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07694258

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Disorders of Consciousness

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Next Generation Dome Helmet (NGDH)

Study Details

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 Due to Severe Brain Injury

Disorders of Consciousness

Study ID

NCT07694258

Start date

Sep 10, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Focused Ultrasound Neuromodulation

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.

Interventions

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.

Primary outcome measure

  • Feasibility of Bilateral Central Thalamic FUS Neuromodulation [ Time Frame: 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 [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Benjamin Davidson, MD, PhD

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

Jaana Leppala, Masters of Neuroscience

6476852284jaana.leppala@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Benjamin Davidson, MD, PhD

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

Nir Lipsman, MD, PHD, FRCSC, FAANS

(416)-480-6954Nir.Lipsman@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • focused ultrasound
  • FUS
  • neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-07-09.