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

Primary Purpose

Movement Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rTMS
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Movement Disorders

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toulouse University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active rTMS

sham rTMS

Arm Description

12 patients will be enrolled in this arm.

12 patients will be enrolled in this arm.

Outcomes

Primary Outcome Measures

Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment

Secondary Outcome Measures

Clinical Global Impression-Severity scale (CGI-SEVERITY/CGI-I/CGI-S)
Hospital Anxiety and Depression Scale (HAD/HDRS)
Quality of Life (SF-36)
Temperament and Character Inventory (TCI)
Pain scale (VAS)

Full Information

First Posted
June 10, 2015
Last Updated
July 28, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02471066
Brief Title
rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 : 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active rTMS
Arm Type
Experimental
Arm Description
12 patients will be enrolled in this arm.
Arm Title
sham rTMS
Arm Type
Sham Comparator
Arm Description
12 patients will be enrolled in this arm.
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment
Time Frame
Inclusion and 1 month later
Secondary Outcome Measure Information:
Title
Clinical Global Impression-Severity scale (CGI-SEVERITY/CGI-I/CGI-S)
Time Frame
inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
Title
Hospital Anxiety and Depression Scale (HAD/HDRS)
Time Frame
inclusion, inclusion + 1 month, inclusion + 6 months, inclusion + 12 months.
Title
Quality of Life (SF-36)
Time Frame
inclusion, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
Title
Temperament and Character Inventory (TCI)
Time Frame
inclusion, inclusion + 12 months.
Title
Pain scale (VAS)
Time Frame
: inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Toulouse University Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21480152
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.
Results Reference
background
PubMed Identifier
23385844
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.
Results Reference
background
PubMed Identifier
31180620
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.
Results Reference
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rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy

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