Psychogenic ParalysisPARALYSTIMNCT01352910
rTMS and Functional Paralysis
A study testing rTMS in people with Psychogenic Paralysis, run by University Hospital, Rouen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Psychogenic Paralysis
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2011to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 14 years old
- Psychogenic paralysis according to the DSM-IV-R
Who cannot join
- Contra-indication of rTMS
- Pregnancy or breast-feeding
- Previous history of epilepsia
- Previous session of rTMS (for any indication)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Caen University Hospital
Caen, 14000
Rouen University Hospital
Rouen, 76031
About this study
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.
Read more
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.
- Conditions
- Psychogenic Paralysis
- Being tested
- rTMS, Sham rTMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
120 pulses 0.2 Hz
Sham rTMSDevice
120 pulses 0.2 Hz
| Study group | Role | What they receive |
|---|---|---|
| effective rTMS | Experimental | Not described Receives: Device: rTMS |
| Sham rTMS | Sham comparator | Not described Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators
Measured: D2
Secondary outcomes (3)
Number of side effects occurred during the 2 days of rTMS, between D0 and D1
Measured: D0, D1, D2
Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1
Measured: D0, D1 and D2
Degree of paralysis at D60, quantified by an interview and a standardized examination
Measured: D60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychogenic ParalysisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Caen
- Responsible party
- Sponsor
- Investigators
- Nathalie Chastan, MD PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352910
- Sponsor's protocol ID
- 2010/082/HP
- Acronym
- PARALYSTIM
- Status last verified
- Aug 2016
- First submitted
- 11 May 2011
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35098613
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS and Functional Paralysis
- ClinicalTrials.gov ID
- NCT01352910
- Acronym / sponsor ID
- PARALYSTIM / 2010/082/HP
- Conditions
- Psychogenic Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- University Hospital, Caen
- Study start
- Sep 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| effective rTMS | Experimental | Device: rTMS |
| Sham rTMS | Sham comparator | Device: Sham rTMS |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 14 years old
- Psychogenic paralysis according to the DSM-IV-R
Key exclusion criteria (4 listed)
- Contra-indication of rTMS
- Pregnancy or breast-feeding
- Previous history of epilepsia
- Previous session of rTMS (for any indication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS120 pulses 0.2 Hz | Device | effective rTMS |
| Sham rTMS120 pulses 0.2 Hz | Device | Sham rTMS |
Primary outcome
Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators
Time frame: D2
3 secondary outcomes
Number of side effects occurred during the 2 days of rTMS, between D0 and D1
Time frame: D0, D1, D2
Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1
Time frame: D0, D1 and D2
Degree of paralysis at D60, quantified by an interview and a standardized examination
Time frame: D60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Results publication: PubMed 35098613Chastan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Chastan, MD PhD principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Psychogenic Paralysis, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators (time frame: D2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01352910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.