Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
结局指标
主要结局
Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder
时间窗: 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.
次要结局
- Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)(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)(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)(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)(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)(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)(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)(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.)
研究者
Dr. Nir Lipsman
Principal Investigator MD, PHD, FRCSC, FAANS
Sunnybrook Health Sciences Centre