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

Официальное название

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

Обзор

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.

Подробное описание

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)

Вмешательства

• Устройство Next Generation Dome Helmet (NGDH)
  Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation, spaced four weeks apart, using the Next Generation Dome Helmet device. Treatments will target regions within the CSTC circuit identified by advanced MRI scans. Each session will include pre-treatment assessments, precise sonications of deep brain structures, real-time safety monitoring, and post-treatment imaging.

Первичные конечные точки

• Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder [Срок оценки: 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.]

Вторичные конечные точки (7)

• Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Sunnybrook Health Sciences Centre — Toronto

Идентификаторы

NCT: NCT07704632 · 6791

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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