Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- ReStore System Safety
研究概览
简要总结
Objectives of this study are to provide continued safety assessment for the ReStore system, and to gain further estimates of the effect size of Vagus Nerve Stimulation (VNS) therapy with Prolonged Exposure Therapy (PE) compared to PE with placebo (sham) stimulation in participants with posttraumatic stress disorder (PTSD)
详细描述
A prospective, multi-center, randomized, controlled, blinded trial of participants implanted with the ReStore Device for VNS Therapy.
In double-blinded Phase 1, after implantation, participants will be randomized to either active VNS stimulation or sham VNS stimulation, accompanying PE therapy twice weekly for 7 weeks (12 in-office sessions, Phase 1). The therapist and the participant will be blinded of the group assignment.
Following completion of Phase 1, all participants undergo two mid-therapy assessments and then advance to the open-label Phase 2.
In open-label Phase 2, all participants will receive up to an additional 12 sessions of PE therapy paired with active VNS stimulation, regardless of their prior assignment in Phase 1.
Post-therapy assessments will be performed 1 day, 1 month, and 6 months following the completion of the final session of PE in Phase 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All are blinded in the RCT (Randomized Controlled Trial) phase. However, sites will need to have an unblinded programmer who is only programming the device and not collecting outcomes data
入排标准
- 年龄范围
- 22 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria
- •In the medical opinion of the Principal Investigator (PI), failed at least one adequate course of first-line PTSD treatment per American Psychological Association (APA) guidelines
- •PCL-5 score greater than 33
- •Age 22-79 years
- •Appropriate surgical candidate for VNS device implantation
- •Willing and able to comply with study protocol
- •Able to provide informed consent.
排除标准
- •Currently undergoing prolonged exposure therapy elsewhere
- •Concurrent participation in another interventional clinical trial
- •Prior injury to vagus nerve
- •Prior or current treatment with vagus nerve stimulation
- •Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
- •Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version
- •Persons with a current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability or (b) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation:
- •may pose a significant or undue risk to the person,
- •make it unlikely the person will complete all the study requirements per protocol, or
- •may adversely impact the integrity of the data or the validity of the study results
- •Persons with a neck circumference larger than 18.5 inches
- •Females of childbearing potential who are either pregnant or planning to become pregnant and who are not using, or will not agree to use medically acceptable birth control methods
- •Non-English speaking
- •As determined by the principal investigator, is under current incarceration or legal detention
研究组 & 干预措施
Immediate VNS Group
The participants in this arm will be implanted with the device and will receive active VNS stimulations in phase 1 as well as phase 2 of the study.
干预措施: Active VNS stimulation (Device)
Delayed VNS Group
The participants in this arm will be implanted with the device but will receive sham VNS stimulations in phase 1 of the study and active VNS in phase 2 of the study.
干预措施: Sham VNS stimulation (Device)
结局指标
主要结局
ReStore System Safety
时间窗: From surgery to up to 2 years following implantation or until the device is FDA approved, whichever comes first
ReStore System safety by review of any adverse events
次要结局
- PostTraumatic Cognitions Inventory (PTCI)(From baseline up to visit 33 (end of study))
- PTSD Checklist for DSM-5 (PCL-5) score(From baseline up to visit 33 (end of study))
- Clinician Administered PTSD Scale for DSM-5(fifth edition of the Diagnostic and Statistical Manual of Mental Disorders)(CAPS-5)(From baseline up to visit 33 (end of study))
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(From baseline up to visit 33 (end of study))
- Patient Health Questionnaire-9 (PHQ-9)(From baseline up to visit 33 (end of study))
研究者
Dr. Seth Hays
Professor
The University of Texas at Dallas