Psychogenic Paralysis Clinical Trial
— PARALYSTIM| Verified date | August 2016 |
| Source | University Hospital, Rouen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Institutional Ethical Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Caen University Hospital | Caen | |
| France | Rouen University Hospital | Rouen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Rouen | University Hospital, Caen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators | D2 | No | |
| Secondary | Number of side effects occurred during the 2 days of rTMS, between D0 and D1 | D0, D1, D2 | Yes | |
| Secondary | Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1 | D0, D1 and D2 | Yes | |
| Secondary | Degree of paralysis at D60, quantified by an interview and a standardized examination | D60 | No |