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

2 juli 2026 bijgewerkt door: Dr. Benjamin Davidson, Sunnybrook Health Sciences Centre

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a prospective, single-center, single-arm, open-label pilot clinical trial. Approximately 10-15 participants are expected to be enrolled. Each participant will receive two sessions of low-intensity focused ultrasound (FUS) neuromodulation targeting the bilateral central thalamus, spaced four weeks apart, plus or minus one week. Participants will be followed for safety, clinical, imaging, and neurophysiological assessments, including follow-up through 12 weeks after the second treatment and, when clinically feasible, at 12 months post-injury.

Studietype

Ingrijpend

Inschrijving (Geschat)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility of Bilateral Central Thalamic FUS Neuromodulation
Tijdsspanne: 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.
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
Tijdsspanne: 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.
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Behavioral Responsiveness (Coma Recovery Scale-Revised, CRS-R)
Tijdsspanne: 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.
The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment used to measure level of consciousness in patients with disorders of consciousness. The CRS-R consists of 6 subscales (Auditory, Visual, Motor, Oromotor/Verbal, Communication, and Arousal) that evaluate reproducible signs of awareness. Total scores range from 0 to 23, with higher scores indicating greater behavioral responsiveness and higher levels of consciousness.
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)
Tijdsspanne: 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.

The Glasgow Coma Scale (GCS) is a standardized clinical tool used to assess a patient's level of consciousness, particularly after brain injury. It evaluates three components of responsiveness: eye opening, verbal response, and motor response.

Each component is scored individually and then summed to produce a total score ranging from 3 to 15. Higher scores indicate better neurological function and greater levels of consciousness, while lower scores reflect more severe impairment.
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
Tijdsspanne: 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.
The Rancho Los Amigos Scale (also known as the Rancho Los Amigos Levels of Cognitive Functioning Scale) is an 8-level clinical scale used to assess cognitive recovery and behavioral responsiveness following severe brain injury. The scale ranges from Level I (No Response) to Level VIII (Purposeful and Appropriate Response). Higher levels indicate greater cognitive functioning, improved awareness, and more appropriate and consistent behavioral responses. Only participants who scored 23 on CRS-R will complete The Rancho Los Amigos Scale.
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
Tijdsspanne: Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.

Electroencephalography (EEG) will be used to assess changes in neural activity before and after focused ultrasound (FUS) neuromodulation. EEG measures will include spectral power (frequency band power across delta, theta, alpha, beta, and gamma ranges), spectral entropy (a measure of signal complexity and cortical activation), and event-related responses during task-based paradigms (e.g., motor imagery and passive auditory language tasks).

Higher spectral entropy and increased task-related cortical responses are generally interpreted as reflecting greater cortical activation and improved network engagement associated with arousal and awareness. Changes in resting-state spectral power and task-evoked responses will be assessed relative to baseline.
Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
Change in Resting-State Functional Connectivity (rs-fMRI)
Tijdsspanne: Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
Resting-state functional MRI will be used to assess changes in resting-state functional connectivity between the central thalamus and frontal/parietal cortical regions. Connectivity may be quantified using seed-based connectivity metrics and network-level connectivity measures derived from resting-state data. Changes will be assessed relative to baseline.
Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
Change in Task-Based Functional Connectivity
Tijdsspanne: Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
Task-based functional MRI will be used to assess brain activation and network engagement during structured paradigms, such as motor imagery and passive auditory language tasks. Task-related blood-oxygen-level-dependent (BOLD) responses will be used to assess regional brain activation and network-level engagement. Changes will be assessed relative to baseline.
Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sunnybrook Health Sciences Centre

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 september 2025

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 september 2028

Studieregistratiedata

Eerst ingediend

2 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juli 2026

Eerst geplaatst (Werkelijk)

9 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 6798

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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