rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy

Study Overview
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Brief Summary
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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

Official Title
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Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Functional Psychogenic Movement Disorders Followed by a Feasibility Study of a Hypnotherapy Treatment as Adjuvant Therapy.

Conditions
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Movement Disorders

Intervention / Treatment
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* Device: rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: Severe progressive psychiatric disorders Cardiac pace-maker Metallic prosthesis Cochlear implants Previous neurosurgery Epilepsy Severe cardiac disease Alcohol or toxic abuse for the last 12 months Drugs such clozapine, bupropion, methadone or theophylline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active rTMS<br>12 patients will be enrolled in this arm. | Device: rTMS<br>* Study 1 : 5 daily sessions of rTMS 1 Hz, 95% x resting motor threshold (RMT) applied on M1 / sham Study 2 : 3 weekly sessions of rTMS 1 Hz, 95% x RMT on M1 combined with ericksonian hypnosis session<br>|
| Sham Comparator: sham rTMS<br>12 patients will be enrolled in this arm. | Device: rTMS<br>* Study 1 : 5 daily sessions of rTMS 1 Hz, 95% x resting motor threshold (RMT) applied on M1 / sham Study 2 : 3 weekly sessions of rTMS 1 Hz, 95% x RMT on M1 combined with ericksonian hypnosis session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment |  | Inclusion and 1 month later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. |