Assessment of Safety and Feasibility of Focused Ultrasound (FUS) Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Substance Use Disorder (SUD)
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
- Incidence and Severity of Adverse Events
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, feasibility, and preliminary clinical benefit of focused ultrasound (FUS) neuromodulation using the FUS Next Generation Dome Helmet (NGDH) in adults with treatment-resistant moderate-to-severe substance use disorder (SUD).
The main questions it aims to answer are:
Can FUS neuromodulation be safely delivered to the nucleus accumbens (NAc) and/or anterior insula (aI)? Does FUS neuromodulation result in reduced substance use severity, as measured by Timeline Followback (TLFB), by 4 weeks post-treatment?
Participants will:
Complete baseline clinical assessments, questionnaires, imaging, and safety assessments.
Undergo two MRI-guided FUS neuromodulation sessions approximately 4 weeks apart.
Attend follow-up visits for safety monitoring, symptom assessments, quality-of-life measures, and additional imaging where applicable.
详细描述
A total of 20 participants with treatment-resistant moderate-to-severe substance use disorder (SUD) will be enrolled and treated in this study. Participants will be enrolled from the local practices of the psychiatrists/addiction physicians involved in the study and through outside referrals, including physician referrals or self-referrals. Patient eligibility will be assessed at a screening appointment by the study coordinator and a physician associated with the study. The anticipated enrollment period is approximately two years.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be deemed to have capacity to provide informed consent (determined by the investigator)
- •Age between 18 to 70 (inclusive)
- •Diagnosis of SUD (cannabis, alcohol, ketamine, stimulant, opioid or nicotine/tobacco use disorder) in the moderate to severe range according to the DSM-5
- •Previous ≥2 pharmacotherapy trials for the diagnosed SUD according to guideline-concordant, evidence-based care
- •On a stable regimen of their psychiatric medications for 30 days before enrolment.
排除标准
- •Pregnant or intending to be pregnant during the study
- •Known active seizure disorder, significant head injury with an imaging verified lesion
- •Medical illness that is deemed to be unstable or may confound the effects of the intervention
- •Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
- •Unable to reliably attend the required screening, treatment, and follow up appointments.
- •Severe claustrophobia, identified by the subject to be a limiting factor preventing MRI.
- •Scores 18 or below on Montreal Cognitive Assessment (MoCA)
- •Weighs 250 lbs or more.
结局指标
主要结局
Incidence and Severity of Adverse Events
时间窗: From baseline (prior to first treatment) through 4 weeks after the second treatment, including assessments on the day of each treatment, 1 day, 1 week, and 2 weeks after each treatment, and at 4 weeks after the second treatment.
Safety will be evaluated by assessing the incidence, severity, and relationship of adverse events associated with FUS neuromodulation.
次要结局
- Change in Number of Drinking Days Using the Timeline Followback (TLFB)(Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment)
- Change in Average Number of Drinks per Drinking Day Using TLFB(Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment)
- Change in Percent Days Abstinent Using TLFB(Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment)
- Change in Number of Heavy Drinking Days Using TLFB(Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment)
- Subjective Ratings of Mood, Anxiety, Energy, and Optimism Using 1-9 Likert Scales(Baseline, immediately before and after each treatment, 24 hours after each treatment, and 2 and 4 weeks after the second treatment)
- Change in Depressive Symptoms Using the Hamilton Depression Rating Scale (HAMD-17)(Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment)
- Change in anxiety symptoms using the Beck Anxiety Inventory (BAI)(Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment)
- Change in drug use severity using the Drug Use Disorders Identification Test (DUDIT)(Baseline, 3 months after the second treatment, and 6 months after the second treatment)
- Barratt Impulsiveness Scale (BIS-11)(Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment)
- DSM-5 substance use disorders symptom checklist(Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment.)
- The Colorado Symptom Index (CSI)(Baseline, 2 weeks after the first treatment, and 2 and 4 weeks after the second treatment)
研究者
Dr. Nir Lipsman
Principal Investigator MD, PHD, FRCSC, FAANS
Sunnybrook Health Sciences Centre