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Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)

10 luglio 2026 aggiornato da: Dr. Nir Lipsman, Sunnybrook Health Sciences Centre

Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)

This study evaluates the safety, feasibility, and preliminary efficacy of focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) in participants with treatment-refractory obsessive-compulsive disorder (OCD). Participants will undergo two study sessions, four weeks apart, involving active FUS neuromodulation targeting nodes of the cortico-striato-thalamo-cortical (CTSC) circuit. Outcomes include adverse events, changes in OCD symptom severity, and quality of life.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is designed as a prospective, single arm, nonrandomized study aiming to evaluate safety and tolerability of transcranial focused ultrasound neuromodulation targeting CTSC circuit nodes (including VC/VS, STN, ACC, OFC, and caudate nucleus).

Twenty participants with treatment-refractory OCD will be enrolled. Each participant will receive two treatment sessions (4 weeks apart)

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Reclutamento
        • Sunnybrook Health Sciences Centre
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Must be deemed to have the capacity to provide informed consent.
  2. Age 18 to 85 years.
  3. Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria.
  4. Yale-Brown Obsessive Compulsive Scale total score greater than 22.
  5. If taking psychiatric medications, must be on a stable regimen for at least 30 days before enrollment. Psychiatric medications will be continued throughout the study.
  6. Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists.
  7. Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks.

Exclusion Criteria:

  1. Pregnant or intending to become pregnant during the study.
  2. Substance use disorder, other than cannabis or nicotine use disorder, of moderate severity or greater, or where the substance is the primary substance of concern, according to DSM-5 criteria.
  3. Known active seizure disorder or significant head injury with an imaging-confirmed lesion.
  4. Unstable medical illness.
  5. Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device.
  6. Unable to reliably attend the required screening, treatment, and follow-up visits.
  7. Severe claustrophobia that would prevent MRI scanning.
  8. History of a bleeding disorder or coagulopathy.

  9. Anticoagulant therapy or use of medications known to increase the risk of hemorrhage within the required washout period before treatment, including:

    • Antiplatelet agents or vitamin K antagonist anticoagulants within 7 days of treatment
    • Non-vitamin K oral anticoagulants within 72 hours of treatment
    • Heparin-derived compounds within 48 hours of treatment

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Focused Ultrasound Neuromodulation
Focused Ultrasound Neuromodulation: Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation targeting regions within the cortical-striatal-thalamic circuit (CSTC) implicated in treatment-resistant depression. Treatments will be spaced four weeks apart. All participants will receive the same intervention and will be followed for 4 weeks post-treatment to evaluate clinical outcomes, adverse events, and depression symptoms.
Dispositivo: Casco a cupola di prossima generazione (NGDH)
I partecipanti riceveranno due sessioni di neuromodulazione ad ultrasuoni focalizzati a risonanza magnetica, distanziata a quattro settimane di distanza, usando il dispositivo del casco a cupola di prossima generazione. I trattamenti prendono di mira le regioni all'interno del circuito CSTC identificato da scansioni MRI avanzate. Ogni sessione includerà valutazioni pre-trattamento, sotterranei precise di strutture cerebrali profonde, monitoraggio della sicurezza in tempo reale e imaging post-trattamento.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder
Lasso di tempo: Assessments will be conducted at the baseline visit; on the day of each of the two treatments; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
Assessment of the frequency and severity of adverse events associated with focused ultrasound neuromodulation in patients with treatment-refractory obsessive-compulsive disorder. Adverse events, including procedure-related complications and neurological events, will be documented and assessed.
Assessments will be conducted at the baseline visit; on the day of each of the two treatments; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Lasso di tempo: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
Evaluate the effectiveness of FUS Neuromodulation in reducing obsessive-compulsive symptom severity using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The Y-BOCS is a clinician-administered scale assessing the severity of obsessive-compulsive symptoms. Total scores range from 0 to 40, with higher scores indicating greater symptom severity (0-7 subclinical, 8-15 mild, 16-23 moderate, 24-31 severe, and 32-40 extreme).
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
Change in Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Lasso di tempo: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a self-report measure assessing quality of life across multiple domains. Total scores are typically transformed into a percentage of the maximum possible score, with higher percentages indicating greater life satisfaction and functioning. Change from baseline will be evaluated at each assessment time point.
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
Change in Obsessive-Compulsive Symptoms as Measured by the Obsessive Compulsive Inventory (OCI)
Lasso di tempo: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
The Obsessive Compulsive Inventory is a self-report measure used to assess obsessive-compulsive symptoms. Higher scores indicate greater symptom severity. Change from baseline will be evaluated at each assessment time point.
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
Change in Anxiety Symptoms as Measured by the Beck Anxiety Inventory (BAI)
Lasso di tempo: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
The Beck Anxiety Inventory (BAI) is a 21-item self-report scale assessing the severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity (0-7 minimal, 8-15 mild, 16-25 moderate, and 26-63 severe anxiety). Change from baseline will be evaluated at each assessment time point.
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7)
Lasso di tempo: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
The GAD-7 is a 7-item self-report questionnaire used to assess generalized anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 5, 10, and 15 represent commonly used thresholds for mild, moderate, and severe anxiety, respectively. Change from baseline will be evaluated at each assessment time point.
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
Change in Patient-Reported Outcomes Using Likert Scales (1-9)
Lasso di tempo: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
A brief set of 1-9 Likert scales will be used to assess patient-reported symptoms and subjective experiences. Scores range from 1 to 9, with higher scores indicating greater symptom severity or impact. Change from baseline will be evaluated at each assessment time point.
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
Change in Depressive Symptoms as Measured by the 17-Item Hamilton Depression Rating Scale (HAMD-17)
Lasso di tempo: Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
The HAMD-17 is a clinician-administered scale used to assess the severity of depressive symptoms. Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline will be evaluated at each assessment time point.
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sunnybrook Health Sciences Centre

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 settembre 2025

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

10 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 luglio 2026

Primo Inserito (Effettivo)

15 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 6791

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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