Intermittent Theta-Burst Stimulation (iTBS) as an add-on to Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Post-traumatic Stress Disorder (PTSD): An Open-label Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Drop-out
研究概览
简要总结
This open-label pilot study will evaluate the feasibility, safety, tolerability, and preliminary clinical outcomes of adding intermittent theta-burst stimulation (iTBS) to Eye Movement Desensitization and Reprocessing (EMDR) therapy in adults with post-traumatic stress disorder (PTSD), who show insufficient improvement after an initial course of EMDR.
Participants will receive weekly EMDR therapy. After seven EMDR sessions, treatment response will be assessed using the Clinical Global Impression-Improvement scale (CGI-I). Participants with insufficient response will receive add-on iTBS targeted to the right dorsolateral prefrontal cortex (DLPFC) for four weeks while continuing EMDR. Feasibility outcomes include adherence, treatment completion, and dropout rates. Clinical outcomes will include clinician-rated and self-reported measures of PTSD symptoms, depressive symptoms, well-being, and adverse events.
详细描述
Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition characterized by intrusive traumatic memories, avoidance behaviors, negative alterations in cognition and mood, and persistent hyperarousal. Although trauma-focused psychotherapies such as Eye Movement Desensitization and Reprocessing (EMDR) are recommended as first-line treatments, a substantial proportion of patients continue to meet diagnostic criteria for PTSD despite receiving evidence-based psychotherapy.
Intermittent theta-burst stimulation (iTBS), a brief form of repetitive transcranial magnetic stimulation (rTMS), has demonstrated preliminary efficacy in reducing PTSD symptoms and offers practical advantages due to its short treatment duration.
The present study aims to investigate whether iTBS can be feasibly integrated as an adjunctive intervention for patients who do not respond sufficiently to EMDR therapy alone. This is an investigator-initiated, open-label feasibility study conducted within psychiatric services in the Central Denmark Region.
Eligible adults aged 18 to 70 years with a diagnosis of PTSD, who are referred for EMDR treatment, will be enrolled. Participants will receive standardized EMDR therapy consisting of sixteen weekly 90-minute sessions. Following completion of seven EMDR sessions, treatment response will be evaluated using the Clinical Global Impression-Improvement (CGI-I) scale. Participants rated as having insufficient improvement (CGI-I score ≥3) will be offered add-on iTBS.
The iTBS intervention will be delivered to the right DLPFC using a MagPro R30 stimulator and Cool-B70 coil. Treatment will consist of one daily iTBS session administered five days per week over four weeks for a total of 20 sessions. Participants will continue weekly EMDR therapy throughout the iTBS phase and subsequent follow-up period.
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
- •Age 18-70 years
- •ICD-10 criteria for PTSD (F43.1)
- •A minimum total score of 4 (moderately ill) on the Clinical Global Impression-Severity (CGI-S)
- •Likely to be able to complete trial participation (16 weeks) without modifications to psychopharmacological treatment, as per the referring doctor's or psychologist's assessment
- •Participants must be able and willing to abstain from alcohol consumption during the iTBS treatment period, as required by the TMS Safety Checklist.
排除标准
- •Organic mental disorders (F0)
- •Currently fulfills the criteria of Active psychoactive substance use or dependence (F1)
- •Schizophrenia, schizotypal and delusional disorders (F2), manic episode (F30), or bipolar affective disorder (F31); iv) Mental retardation (estimated IQ <70, as per the referring doctor's or psychologist's assessment)
- •Active suicidality
- •Any ongoing involuntary/coercive measures
- •Any contraindications listed on the TMS Safety Checklist
结局指标
主要结局
Drop-out
时间窗: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
The primary outcome will be drop-out rates
Treatment completion rates
时间窗: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
The second primary outcome will be treatment completion rates (number of iTBS treatments received out of the planned 20 treatments)
次要结局
- Symptom trajectories(From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks))
- Adverse event rates(From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks))
- Adverse event rates(Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks))
- Changes in mental well-being(From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks))
研究者
Pernille Kølbæk
Regional Clinical Research Coordinator, Associate professor
Aarhus University Hospital