NCT02471066

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

2.8 years

First QC Date

June 10, 2015

Last Update Submit

July 28, 2020

Conditions

Movement Disorders

Outcome Measures

Primary Outcomes (1)

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

    Inclusion and 1 month later

Secondary Outcomes (5)

  • 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.

Study Arms (2)

active rTMS

EXPERIMENTAL

12 patients will be enrolled in this arm.

Device: rTMS

sham rTMS

SHAM COMPARATOR

12 patients will be enrolled in this arm.

Device: rTMS

Interventions

rTMSDEVICE

* 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

active rTMSsham rTMS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse University Hospital

Toulouse, 31000, France

Location

Related 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.

    PMID: 21480152BACKGROUND

  • 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.

    PMID: 23385844BACKGROUND

  • 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.

    PMID: 31180620RESULT

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 12, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

FR(1)