Clinical trial NCT02471066: rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy
Official title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Functional Psychogenic Movement Disorders Followed by a Feasibility Study of a Hypnotherapy Treatment as Adjuvant Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Movement Disorders
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 :

1. to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a double-blind randomized controlled study
2. to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD


Eligibility criteria: 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

Primary outcomes:
measure: Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment
timeFrame: Inclusion and 1 month later
Secondary outcomes:
measure: Clinical Global Impression-Severity scale (CGI-SEVERITY/CGI-I/CGI-S)
timeFrame: inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
measure: Hospital Anxiety and Depression Scale (HAD/HDRS)
timeFrame: inclusion, inclusion + 1 month, inclusion + 6 months, inclusion + 12 months.
measure: Quality of Life (SF-36)
timeFrame: inclusion, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
measure: Temperament and Character Inventory (TCI)
timeFrame: inclusion, inclusion + 12 months.
measure: Pain scale (VAS)
timeFrame: : inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
References:
citation: Dafotakis M, Ameli M, Vitinius F, Weber R, Albus C, Fink GR, Nowak DA. [Transcranial magnetic stimulation for psychogenic tremor - a pilot study]. Fortschr Neurol Psychiatr. 2011 Apr;79(4):226-33. doi: 10.1055/s-0029-1246094. Epub 2011 Apr 8. German.
citation: Garcin B, Roze E, Mesrati F, Cognat E, Fournier E, Vidailhet M, Degos B. Transcranial magnetic stimulation as an efficient treatment for psychogenic movement disorders. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1043-6. doi: 10.1136/jnnp-2012-304062. Epub 2013 Feb 5.
citation: Taib S, Ory-Magne F, Brefel-Courbon C, Moreau Y, Thalamas C, Arbus C, Simonetta-Moreau M. Repetitive transcranial magnetic stimulation for functional tremor: A randomized, double-blind, controlled study. Mov Disord. 2019 Aug;34(8):1210-1219. doi: 10.1002/mds.27727. Epub 2019 Jun 10.