Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD, a Randomized Double Blind Sham Controlled Trial (TraumaStim)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- PTSD severity score measured at M1 after 12 sessions of rTMS or sham rTMS and simultaneous reactivation of traumatic memory
研究概览
简要总结
A French multicenter randomized and double blinded shamed controlled study recruiting patients who present resistant PTSD. The aim of this trial is to assess the efficacy of cerebral modulation by rTMS with simultaneous reactivation of traumatic memory on the PTSD symptoms at M1.
详细描述
Detailed Description : PTSD is considered as one of the top 10 public health concerns. Most patients with PTSD receive pharmacologic treatment and traumatic reactivation therapy. However, to date, the optimal treatment alternatives for non-responders PTSD patients are unknown.
Functionally, the metabolic activity of the prefrontal-amygdala cortex circuit in PTSD is significantly altered. Repetitive Transcranial Magnetic Stimulation (rTMS) provides focused, non-invasive stimulation of cortical areas of the central nervous system and could correct cortical defective activation of the prefrontal cortex seen in PTSD Patient (FDA has already approved rTMS for depression and acoustic-verbal hallucinations treatment).
Pairing rTMS with cues relevant to the trauma may be a novel approach to treat PTSD patient.
The study will enroll 102 subjects with resistant PTSD. After screening and inclusion phase, the treatment phase with 12 sessions of rTMS and simultaneous reactivation of traumatic memory or sham rTMS and simultaneous reactivation of traumatic memory will be performed (3 to 4 weeks). Antidepressant treatment will be maintained. The follow up phase consist of 3 visits at M1, M3 and M6 to follow the evolution of the PTSD symptoms.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years.
- •Presenting a PTSD according to DSM-5 criteria
- •Patient with persistent symptoms (PCL-5>40) after a 6 weeks treatment with labelled antidepressant for PTSD (paroxetine or sertraline)
- •Patient with health insurance (AME excepted)
- •Signed written inform consent
- •Exclusion Criteria :
- •Contraindication for rTMS:
- •History of epilepsy or seizure
- •Cochlear implants
- •Cardiac pacemaker or intracardiac lines, or metal in the body
- •Patient has already had a rTMS session and/or Electroconvulsive therapy (ECT) and/or Transcranial direct current stimulation (tDCS)
- •Ongoing PTSD-oriented cognitive-behavioral therapy
- •Lifetime psychotic or bipolar disorder or antisocial personality or borderline personality
- •Brain injury defined by medical report (including cortical and subcortical atrophy, dementia, stroke, transient ischemic attack and head trauma)
- •Current substance dependence (including alcohol, excluding tobacco);
- •Acute suicidal ideation
- •No adequate mastering of the French language or no ability to consent
- •Pregnancy (confirmed by a urine test beta-HCG) or breast feeding or absence of birth control
- •Patient under legal protection measure and or deprived of freedom
- •Participation in any other interventional study or in the exclusion period any other interventional study
排除标准
- 未提供
结局指标
主要结局
PTSD severity score measured at M1 after 12 sessions of rTMS or sham rTMS and simultaneous reactivation of traumatic memory
时间窗: Month 1 after 12 sessions of rTMS
CAPS-5 total severity score at M1 post treatment will be compared between groups (cerebral modulation by rTMS with simultaneous reactivation of traumatic memory VS sham rTMS with simultaneous reactivation of traumatic memory)
次要结局
- The severity of PTSD assessed by PCL-5 at each visit.(at once a during TMS sessions, Month1, Month 3 and Month 6 post treatment.)
- Dissociative symptoms severity scores (1)(at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment)
- PTSD severity scores at M3 and M6 measured with CAPS-5(At inclusion (v1), Month 3 and Month 6 post treatment)
- Symptoms of depression at V13 (end of treatment), M1, M3, M6 post treatment.(at V13 (end of treatment), Month 1, Month 3, Month 6 post treatment.)
- Dissociative symptoms severity scores (3)(at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment)
- The severity scores of the dimensions of anxiety at V13 (end of treatment), M1, M3, M6 post treatment.(Up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment.)
- Dissociative symptoms severity scores (2)(at inclusion (V1), up to 4 weeks (V13) (end of treatment), Month 1, Month 3, Month 6 post treatment)
- Evolution of social cognition at M3 post treatment.(at Month 3 post treatment)
- Proportion of adverse events during the active treatment phase and during the follow-up(through study completion, up to 6 months)
- Quality of life(post treatment and Month 6)