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

Movement Disorders Clinical Trial

— MOVHYSTIM  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471066
• Other study ID #: 14 7311 02
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 2018

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Movement Disorders

Intervention

Device:
• rTMS
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

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment		Inclusion and 1 month later
Secondary	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.
Secondary	Hospital Anxiety and Depression Scale (HAD/HDRS)		inclusion, inclusion + 1 month, inclusion + 6 months, inclusion + 12 months.
Secondary	Quality of Life (SF-36)		inclusion, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
Secondary	Temperament and Character Inventory (TCI)		inclusion, inclusion + 12 months.
Secondary	Pain scale (VAS)		: inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.