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NCT Number: NCT02471066

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

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

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Key information

Conditions

Movement Disorders Central Nervous System Diseases Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toulouse University Hospital

Toulouse, 31000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS

Device
  • 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 outcomes

  1. 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 outcomes

  1. 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.

  2. Hospital Anxiety and Depression Scale (HAD/HDRS)

    Time frame: inclusion, inclusion + 1 month, inclusion + 6 months, inclusion + 12 months.

  3. Quality of Life (SF-36)

    Time frame: inclusion, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.

  4. Temperament and Character Inventory (TCI)

    Time frame: inclusion, inclusion + 12 months.

  5. Pain scale (VAS)

    Time frame: : inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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.

Acronym: MOVHYSTIM

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2015
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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