Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)
10 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Anusha Baskaran, PhD
- Número de teléfono: 61650 416-480-6100
- Correo electrónico: anusha.baskaran@sunnybrook.ca
Copia de seguridad de contactos de estudio
- Nombre: Nir Lipsman, MD, PHD, FRCSC, FAANS
- Número de teléfono: (416)-480-6954
- Correo electrónico: Nir.Lipsman@sunnybrook.ca
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M4N 3M5
- Reclutamiento
- Sunnybrook Health Sciences Centre
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Contacto:
- Anusha Baskaran, PhD
- Número de teléfono: 61650 416-480-6100
- Correo electrónico: anusha.baskaran@sunnybrook.ca
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Must be deemed to have the capacity to provide informed consent.
- Age 18 to 85 years.
- Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria.
- Yale-Brown Obsessive Compulsive Scale total score greater than 22.
- 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.
- Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists.
- Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks.
Exclusion Criteria:
- Pregnant or intending to become pregnant during the study.
- 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.
- Known active seizure disorder or significant head injury with an imaging-confirmed lesion.
- Unstable medical illness.
- Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device.
- Unable to reliably attend the required screening, treatment, and follow-up visits.
- Severe claustrophobia that would prevent MRI scanning.
- History of a bleeding disorder or coagulopathy.
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Los participantes recibirán dos sesiones de neuromodulación de ultrasonido enfocada con resonancia magnética, espaciadas con cuatro semanas de diferencia, utilizando el dispositivo de casco domo de próxima generación.
Los tratamientos se dirigirán a regiones dentro del circuito CSTC identificados por escaneos de resonancia magnética avanzada.
Cada sesión incluirá evaluaciones previas al tratamiento, sonicaciones precisas de estructuras cerebrales profundas, monitoreo de seguridad en tiempo real e imágenes posteriores al tratamiento.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder
Periodo de tiempo: 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.
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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.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Periodo de tiempo: 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.
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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).
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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.
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Change in Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Periodo de tiempo: 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.
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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.
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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.
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Change in Obsessive-Compulsive Symptoms as Measured by the Obsessive Compulsive Inventory (OCI)
Periodo de tiempo: 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.
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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.
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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.
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Change in Anxiety Symptoms as Measured by the Beck Anxiety Inventory (BAI)
Periodo de tiempo: 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.
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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.
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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.
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Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: 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.
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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.
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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.
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Change in Patient-Reported Outcomes Using Likert Scales (1-9)
Periodo de tiempo: 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.
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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.
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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.
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Change in Depressive Symptoms as Measured by the 17-Item Hamilton Depression Rating Scale (HAMD-17)
Periodo de tiempo: 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.
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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.
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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.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de septiembre de 2025
Finalización primaria (Estimado)
1 de septiembre de 2027
Finalización del estudio (Estimado)
1 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
10 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de julio de 2026
Publicado por primera vez (Actual)
15 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 6791
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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