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临床试验/NCT04064762
NCT04064762进行中(未招募)不适用

Targeted Plasticity Therapy for Posttraumatic Stress Disorder

Baylor Research Institute2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2020年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
9
试验地点
2
主要终点
Incidence of Adverse Events [Device Safety]

研究概览

简要总结

Posttraumatic stress disorder is a debilitating condition that develops in the aftermath of a traumatic experience, leading to hyperarousal, heightened anxiety, and uncontrolled fear that can be driven by intrusive memories or trauma reminders. The Texas Biomedical Device Center has developed a novel technique, termed targeted plasticity therapy (TPT), to boost neuroplasticity in conjunction with various forms of rehabilitation, including prolonged exposure therapy. The technique involves stimulation of the vagus nerve. The purpose of this open-label pilot study is to assess the safety of using a new device to deliver vagus nerve stimulation to reduce symptom severity in participants with PTSD when paired with prolonged exposure therapy. Additionally, the study will assess the prospective benefit of the system and garner an initial estimate of efficacy for a subsequent trial.

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 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of Adverse Events [Device Safety]

时间窗: From Week 1 through study follow-up, approximately two years from the date of implant

Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore system and provide a better understanding of risk/benefit analysis.

次要结局

  • PTSD Checklist for DSM-5 (PCL-5)(Weeks 1, 9-15, 19, 36, 62)
  • Generalized Anxiety Disorder 7-item Scale (GAD-7)(Weeks 9, 15, 19, 36, 62)
  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)(Weeks 1, 9, 15, 19, 36, 62)
  • Patient Health Questionnaire-9 (PHQ-9)(Weeks 1, 9-15, 19, 36, 62)
  • Posttraumatic Cognitions Inventory (PTCI)(Weeks 9-15, 19, 36, 62)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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