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Completed

NCT Number: NCT01352910

rTMS and Functional Paralysis

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital, Caen, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

rTMS

Device

120 pulses 0.2 Hz

sham rTMS

Device

120 pulses 0.2 Hz

Primary outcomes

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

    Time frame: D2

Secondary outcomes

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

    Time frame: D0, D1, D2

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

    Time frame: D0, D1 and D2

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

    Time frame: D60

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • University Hospital, Caen

Registry information

Acronym: PARALYSTIM

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 12, 2011
Registry last updated
Apr 20, 2026

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

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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.