Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Functional Psychogenic Movement Disorders Followed by a Feasibility Study of a Hypnotherapy Treatment as Adjuvant Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment
研究概览
简要总结
The management of functional psychogenic movement disorders (FNPMD) is challenging for neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme can be worthwhile for these patients (Moene et al 2002). Recent functional magnetic resonance imaging studies have demonstrated abnormalities in motor control at cortical level, hyperactivity of limbic system and disturbance of connectivity between these two systems leading to a lack of self-agency, (Voon et al 2010,2011).Two recent studies suggested a possible therapeutic effect of transcranial magnetic stimulation (TMS) in FNPMD (Dakotakis 2011, Garcin, 2013).
In this protocol our objectives are twofold :
- to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a double-blind randomized controlled study
- to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman with FNPMD for at least 2 months,
- •diagnosed from clinical Diagnostic and Statistical Manual V conversive somatoform troubles and Gupta & Lang (2009) and Edwards & Bahtia 2012 neurological clinical criteria
排除标准
- •Severe progressive psychiatric disorders
- •Cardiac pace-maker
- •Metallic prosthesis
- •Cochlear implants
- •Previous neurosurgery
- •Severe cardiac disease
- •Alcohol or toxic abuse for the last 12 months
- •Drugs such clozapine, bupropion, methadone or theophylline
研究组 & 干预措施
active rTMS
12 patients will be enrolled in this arm.
干预措施: rTMS (Device)
sham rTMS
12 patients will be enrolled in this arm.
干预措施: rTMS (Device)
结局指标
主要结局
Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment
时间窗: Inclusion and 1 month later
次要结局
- Temperament and Character Inventory (TCI)(inclusion, inclusion + 12 months.)
- Pain scale (VAS)(: inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.)
- Clinical Global Impression-Severity scale (CGI-SEVERITY/CGI-I/CGI-S)(inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.)
- Hospital Anxiety and Depression Scale (HAD/HDRS)(inclusion, inclusion + 1 month, inclusion + 6 months, inclusion + 12 months.)
- Quality of Life (SF-36)(inclusion, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.)