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

Not Applicable

Completed

• Conditions: Movement Disorders
• Interventions: Device: rTMS

• Registration Number: NCT02471066
• Lead Sponsor: University Hospital, Toulouse

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham rTMS	rTMS	12 patients will be enrolled in this arm.
active rTMS	rTMS	12 patients will be enrolled in this arm.

Primary Outcome Measures

Name	Time	Method
Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment	Inclusion and 1 month later

Secondary Outcome Measures

Name	Time	Method
Pain scale (VAS)	: inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
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.

Trial Locations

Locations (1)

Toulouse University Hospital; 🇫🇷 Toulouse, France