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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 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

10

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recrutement
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of Bilateral Central Thalamic FUS Neuromodulation
Délai: 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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Behavioral Responsiveness (Coma Recovery Scale-Revised, CRS-R)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sunnybrook Health Sciences Centre

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 septembre 2025

Achèvement primaire (Estimé)

1 septembre 2027

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

2 juillet 2026

Première soumission répondant aux critères de contrôle qualité

2 juillet 2026

Première publication (Réel)

9 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 6798

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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