Early Feasibility Study of Focused Ultrasound (FUS) Neuromodulation in Patients With Opioid Use Disorder and/or Other Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Occurrence of Treatment Emergent Adverse Events
研究概览
简要总结
The primary objective of this study is to assess the safety and feasibility of FUS neuromodulation in participants with OUD and/or other SUDs.
详细描述
This is an open-label early feasibility study investigating low intensity FUS targeting the NAc/VC for participants with OUD and/or other SUDs. Once participants are deemed eligible following Screening/Baseline, participants will undergo FUS in the bilateral NAc/VC with Behavioral and Substance Craving assessments performed prior to, during, and following the treatment. Participants will be assessed during follow-up visits on Day 1, Week 1, 4, 8, and 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 22 - 60 years at time of enrollment.
- •Fulfill current DSM-5 diagnostic criteria for OUD and/or other SUDs with at least a 2-year history.
- •Currently receiving outpatient treatment from the WVU Comprehensive Opioid Addiction
- •Treatment Program (COAT), Intensive Outpatient Program (IOP) or any other program which implements the COAT model; or receiving outpatient/inpatient/residential treatment from similar SUD treatment programs.
- •Currently are under the care of a licensed psychiatrist or other mental health care provider, or a licensed addiction medicine specialist and agrees to promptly inform the investigator or the study staff of any change in these providers.
- •Agrees to allow any and all forms of communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.
排除标准
- •Unable to undergo MR-imaging because of non-MR compatible implants or if candidates are uncomfortable in small spaces (have claustrophobia).
- •History of any clinically significant neurological disorder.
- •History of stroke or brain lesion with observable structural abnormalities in the targeted brain region.
- •Clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments.
- •An abnormal screening result that is considered clinically significant by a medically qualified research team member (i.e., laboratory tests, imaging findings).
- •More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
- •Past or present diagnosis of schizophrenia or psychotic disorder (assessed via SCID-
- •History of medically verified suicide attempt within the past year.
- •Meet the criteria for Cluster A or B Personality Disorders (assessed via SCID-5-PD).
- •Current substance use treatment mandated by court of law.
- •Subject who is currently participating in another clinical investigation with an active
- •treatment arm.
- •Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator
研究组 & 干预措施
LIFU Neuromodulation
Participants will undergo FUS in the bilateral NAc/VC
干预措施: NaviFus Model101 (Device)
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events
时间窗: Beginning Day 0 (the day of the FUS procedure) through Week 4
Incidence of Investigational procedure and device-related adverse Incidence of Investigational procedure and device-related adverse events and SAEs
次要结局
未报告次要终点
研究者
Manish Ranjan
Asst Prof RNI
West Virginia University