NCT01352910

Brief Summary

Psychogenic paralysis presents a real treatment challenge. Despite psychotherapy, physiotherapy, antidepressants, acupuncture or hypnosis, the outcome is not always satisfactory with persistent symptoms after long-term follow-up. In a preliminary retrospective study on 70 patients with psychogenic paralysis (44F/26M, mean age : 24.7 ± 16.6 ys), repetitive transcranial magnetic stimulation (rTMS) delivered over the motor cortex at low frequency was effective in 89% of cases (recovery: n=53, improvement: n=9), with an immediate or quasi-immediate recovery in 73% of patients (n=51). We suggest that the dramatic improvement of psychogenic paralysis after rTMS could be due to the restoration of an appropriate cerebral connectivity by activating a suppressed motor cortex. Nevertheless, the possibility of a placebo effect cannot be ruled out. A prospective multicentric (Rouen, Caen) randomized controlled trial versus placebo will be done for 94 patients with psychogenic paralysis, 1- to evaluate rTMS efficacy for paralysis at short and long term follow-up, and 2- to confirm rTMS safety. Two rTMS sessions will be performed at D0 and D1 (120 pulses over 2 days, delivered over the motor cortex at 2 Hz) with an active or a sham coil. Post-rTMS assessment will evaluate 1- the degree of the paralysis at D2 (quantified by a videotape) and D60 (quantified by an interview and a standardized examination), 2- the number and gravity of side effects. If psychogenic paralysis improvement by motor cortex rTMS is confirmed, rTMS could be considered a useful early therapeutic option.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 20, 2026

Status Verified

August 1, 2016

Enrollment Period

4.8 years

First QC Date

May 11, 2011

Last Update Submit

April 16, 2026

Conditions

Psychogenic Paralysis

Outcome Measures

Primary Outcomes (1)

  • Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators

    D2

Secondary Outcomes (3)

  • Number of side effects occurred during the 2 days of rTMS, between D0 and D1

    D0, D1, D2

  • Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1

    D0, D1 and D2

  • Degree of paralysis at D60, quantified by an interview and a standardized examination

    D60

Study Arms (2)

effective rTMS

EXPERIMENTAL
Device: rTMS

Sham rTMS

SHAM COMPARATOR
Device: Sham rTMS

Interventions

rTMSDEVICE

120 pulses 0.2 Hz

effective rTMS
Sham rTMSDEVICE

120 pulses 0.2 Hz

Sham rTMS

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 14 years old
  • Psychogenic paralysis according to the DSM-IV-R

You may not qualify if:

  • Contra-indication of rTMS
  • Pregnancy or breast-feeding
  • Previous history of epilepsia
  • Previous session of rTMS (for any indication)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Caen University Hospital

Caen, 14000, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (1)

  • Chastan N, Etard O, Parain D, Gerardin P, Fouldrin G, Derambure P, Tard C, Gillibert A, Nathou C, Delval A, Welter ML, Guillin O. Repetitive transcranial magnetic stimulation for patients with functional paralysis: a randomized controlled study. Eur J Neurol. 2022 May;29(5):1293-1302. doi: 10.1111/ene.15264. Epub 2022 Feb 14.

    PMID: 35098613RESULT

Study Officials

  • Nathalie Chastan, MD PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

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

May 11, 2011

First Posted

May 12, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 20, 2026

Record last verified: 2016-08

Locations

FR(2)