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rTMS and Functional Paralysis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01352910
Acronym
PARALYSTIM
Enrollment
66
Registered
2011-05-12
Start date
2011-09-01
Completion date
2016-07-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychogenic Paralysis

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.

Interventions

DEVICErTMS

120 pulses 0.2 Hz

DEVICESham rTMS

120 pulses 0.2 Hz

Sponsors

University Hospital, Rouen
Lead SponsorOTHER
University Hospital, Caen
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinatorsD2

Secondary

MeasureTime frame
Number of side effects occurred during the 2 days of rTMS, between D0 and D1D0, D1, D2
Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1D0, D1 and D2
Degree of paralysis at D60, quantified by an interview and a standardized examinationD60

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNathalie Chastan, MD PhD

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026