Movement DisordersMOVHYSTIMNCT02471066
rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy
A study testing rTMS in people with Movement Disorders, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The management of functional psychogenic movement disorders (FNPMD) is challenging for neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme can be worthwhile for these patients (Moene et al 2002). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Movement Disorders
- 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
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Jan 2018
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman with FNPMD for at least 2 months,
- diagnosed from clinical Diagnostic and Statistical Manual V conversive somatoform troubles and Gupta \& Lang (2009) and Edwards \& Bahtia 2012 neurological clinical criteria
Who cannot join
- Severe progressive psychiatric disorders
- Cardiac pace-maker
- Metallic prosthesis
- Cochlear implants
- Previous neurosurgery
- Epilepsy
Show all 9Show fewer
- Severe cardiac disease
- Alcohol or toxic abuse for the last 12 months
- Drugs such clozapine, bupropion, methadone or theophylline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Functional Psychogenic Movement Disorders Followed by a Feasibility Study of a Hypnotherapy Treatment as Adjuvant Therapy.
The management of functional psychogenic movement disorders (FNPMD) is challenging for neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme can be worthwhile for these patients (Moene et al 2002). Recent functional magnetic resonance imaging studies have demonstrated abnormalities in motor control at cortical level, hyperactivity of limbic system and disturbance of connectivity between these two systems leading to a lack of self-agency, (Voon et al 2010,2011).Two recent studies suggested a possible therapeutic effect of transcranial magnetic stimulation (TMS) in FNPMD (Dakotakis 2011, Garcin, 2013).
In this protocol our objectives are twofold :
- to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a double-blind randomized controlled study
- to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD
- Conditions
- Movement Disorders
- Being tested
- rTMS
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
- Study 1 : 5 daily sessions of rTMS 1 Hz, 95% x resting motor threshold (RMT) applied on M1 / sham
- Study 2 : 3 weekly sessions of rTMS 1 Hz, 95% x RMT on M1 combined with ericksonian hypnosis session
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Experimental | 12 patients will be enrolled in this arm. Receives: Device: rTMS |
| sham rTMS | Sham comparator | 12 patients will be enrolled in this arm. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment
Measured: Inclusion and 1 month later
Secondary outcomes (5)
Clinical Global Impression-Severity scale (CGI-SEVERITY/CGI-I/CGI-S)
Measured: inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
Hospital Anxiety and Depression Scale (HAD/HDRS)
Measured: inclusion, inclusion + 1 month, inclusion + 6 months, inclusion + 12 months.
Quality of Life (SF-36)
Measured: inclusion, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
Temperament and Character Inventory (TCI)
Measured: inclusion, inclusion + 12 months.
Pain scale (VAS)
Measured: : inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471066
- Sponsor's protocol ID
- 14 7311 02
- Acronym
- MOVHYSTIM
- Status last verified
- Jul 2020
- First submitted
- 10 Jun 2015
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Dafotakis M, Ameli M, Vitinius F, Weber R, Albus C, Fink GR, Nowak DA. [Transcranial magnetic stimulation for psychogenic tremor - a pilot study]. Fortschr Neurol Psychiatr. 2011 Apr;79(4):226-33. doi: 10.1055/s-0029-1246094. Epub 2011 Apr 8. German.
PubMed 21480152Garcin B, Roze E, Mesrati F, Cognat E, Fournier E, Vidailhet M, Degos B. Transcranial magnetic stimulation as an efficient treatment for psychogenic movement disorders. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1043-6. doi: 10.1136/jnnp-2012-304062. Epub 2013 Feb 5.
PubMed 23385844Taib S, Ory-Magne F, Brefel-Courbon C, Moreau Y, Thalamas C, Arbus C, Simonetta-Moreau M. Repetitive transcranial magnetic stimulation for functional tremor: A randomized, double-blind, controlled study. Mov Disord. 2019 Aug;34(8):1210-1219. doi: 10.1002/mds.27727. Epub 2019 Jun 10.
PubMed 31180620
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Functional Psychogenic Movement Disorders Followed by a Feasibility Study of a Hypnotherapy Treatment as Adjuvant Therapy.
- ClinicalTrials.gov ID
- NCT02471066
- Acronym / sponsor ID
- MOVHYSTIM / 14 7311 02
- Conditions
- Movement Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 12 Jun 2015 (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.
The management of functional psychogenic movement disorders (FNPMD) is challenging for neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme can be worthwhile for these patients (Moene et al 2002). Recent functional magnetic resonance imaging studies have demonstrated abnormalities in motor control at cortical level, hyperactivity of limbic system and disturbance of connectivity between these two systems leading to a lack of self-agency, (Voon et al 2010,2011).Two recent studies suggested a possible therapeutic effect of transcranial magnetic stimulation (TMS) in FNPMD (Dakotakis 2011, Garcin, 2013).
In this protocol our objectives are twofold :
- to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a double-blind randomized controlled study
- to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD
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 |
|---|---|---|
| active rTMS | Experimental | Device: rTMS12 patients will be enrolled in this arm. |
| sham rTMS | Sham comparator | Device: rTMS12 patients will be enrolled in this arm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Man or woman with FNPMD for at least 2 months,
- diagnosed from clinical Diagnostic and Statistical Manual V conversive somatoform troubles and Gupta \& Lang (2009) and Edwards \& Bahtia 2012 neurological clinical criteria
Key exclusion criteria (9 listed)
- Severe progressive psychiatric disorders
- Cardiac pace-maker
- Metallic prosthesis
- Cochlear implants
- Previous neurosurgery
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 |
|---|---|---|
| rTMS* Study 1 : 5 daily sessions of rTMS 1 Hz, 95% x resting motor threshold (RMT) applied on M1 / sham * Study 2 : 3 weekly sessions of rTMS 1 Hz, 95% x RMT on M1 combined with ericksonian hypnosis session | Device | active rTMS, sham rTMS |
Primary outcome
Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment
Time frame: Inclusion and 1 month later
5 secondary outcomes
Clinical Global Impression-Severity scale (CGI-SEVERITY/CGI-I/CGI-S)
Time frame: inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
Hospital Anxiety and Depression Scale (HAD/HDRS)
Time frame: inclusion, inclusion + 1 month, inclusion + 6 months, inclusion + 12 months.
Quality of Life (SF-36)
Time frame: inclusion, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
Temperament and Character Inventory (TCI)
Time frame: inclusion, inclusion + 12 months.
Pain scale (VAS)
Time frame: : inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.
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 29 Jul 2020.
- Background: PubMed 21480152Dafotakis M, Ameli M, Vitinius F, Weber R, Albus C, Fink GR, Nowak DA. [Transcranial magnetic stimulation for psychogenic tremor - a pilot study]. Fortschr Neurol Psychiatr. 2011 Apr;79(4):226-33. doi: 10.1055/s-0029-1246094. Epub 2011 Apr 8. German.
- Background: PubMed 23385844Garcin B, Roze E, Mesrati F, Cognat E, Fournier E, Vidailhet M, Degos B. Transcranial magnetic stimulation as an efficient treatment for psychogenic movement disorders. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1043-6. doi: 10.1136/jnnp-2012-304062. Epub 2013 Feb 5.
- Results publication: PubMed 31180620Taib S, Ory-Magne F, Brefel-Courbon C, Moreau Y, Thalamas C, Arbus C, Simonetta-Moreau M. Repetitive transcranial magnetic stimulation for functional tremor: A randomized, double-blind, controlled study. Mov Disord. 2019 Aug;34(8):1210-1219. doi: 10.1002/mds.27727. Epub 2019 Jun 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Movement Disorders, run by University Hospital, Toulouse at 1 site 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 9 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment (time frame: Inclusion and 1 month later). 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 NCT02471066, which also lists 3 linked publications.
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 29 Jul 2020.