Congenital Mirror MovementsMOMIC2NCT02073604
Role of the SMA During Unimanual and Bimanual Movements Preparation: the Mirror Movements Paradigm
A study testing Healthy volunteers and Congenital mirror movements in people with Congenital Mirror Movements, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The aim of the project is to study the role of secondary motor area (more precisely the supplementary motor area, or SMA) during unimanual and bimanual voluntary movements externally (cue) or internally (subject's choice) triggered. Read more about this study
- Who is it for?
- Ages 15 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Mirror Movements
- What is being tested?
- Healthy volunteers and Congenital mirror movements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Feb 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 15 to 82 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients aged from 15 years and 3 months to 82 years
- Patients with congenital mirror movements without additional manifestation or malformation
- No contraindications for MRI or TMS study
Who cannot join
- Inability to provide an informed consent
- Simultaneous participation in another clinical trial
- Treatment that modulate cortical excitability (for the TMS part of the study only)
Trial locations and contacts
1 site in 1 country.
France1 site
Fédération des Maladies du Système Nerveux, Hôpital Pitié Salpétrière Paris, France 75013
Paris, 75013
About this study
Official title: Rôle de la SMA Dans la préparation Des Mouvements Uni et Bi-manuels: le Paradigme Des Mouvements en Miroir
The aim of the project is to study the role of secondary motor area (more precisely the supplementary motor area, or SMA) during unimanual and bimanual voluntary movements externally (cue) or internally (subject's choice) triggered. In that view, we will study 3 experimental groups :
- a group of healthy volunteers (control group)
- the same group of healthy volunteers after a transient inactivation of the SMA (by the aim of repetitive trans cranial magnetic stimulation or TMS)
- a group of patients suffering from congenital mirror movements who are suspected to present a dysfunction of the SMA (according to our previous results) In each of these groups, by the aim of a serial reaction time task, we will study the influence of a SMA stimulation on the excitability of the primary motor cortex (M1) during the preparation of a voluntary movement (unimanual or bimanual). This will allow us to assess the communication between the SMA and M1 during movement preparation. Using the same task in functional imagery, we will study the activation's pattern of primary and secondary motor areas during movement preparation. This multimodal approach should allow us to better understand the synergistic functioning of these different structures involved in movement preparation. An other interesting aspect will be to determine the role of these structures in movement lateralization. Eventually, our results might allow us to precise to role of the motor preparation's dysfunction in the genesis of congenital mirror movements.
Read more
In the first place, this study aims at a better understanding of the cerebral physiology of movement preparation (which is not well known) using the mirror movements paradigm as a dysfunction model (according to our previous results). According to our hypothesis, there is a strong link between the SMA and M1 during movement preparation. This hypothesis will be assessed by the use of the same experimental task with combined neurophysiological and neuroimaging approaches, thus increasing the validity of the results obtained.
A secondary aim of this protocol is to precise the role of motor planning dysfunction in patients with congenital mirror movements. A better understanding of the mechanisms responsible for this condition is necessary in a medium-term therapeutic prospect.
- Conditions
- Congenital Mirror Movements
- Being tested
- Healthy volunteers, Congenital mirror movements
- Keywords
- Congenital mirror movements, SMA, Movement preparation, Movement lateralization, MRI, Transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy volunteersOther
Morphological and functional brain MRI; transcranial magnetic stimulation
Congenital mirror movementsOther
Morphological and functional brain MRI; transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Healthy volunteers Receives: Other: Healthy volunteers |
| Congenital mirror movements | Other | Patients presenting with congenital mirror movements Receives: Other: Congenital mirror movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
SMA activation level and connectivity during preparation of unimanual/bimanual movements
Measured: up to 3 years
Secondary outcomes (1)
SMA activation level and connectivity during preparation of unimanual/bimanual movements in congenital mirror movements patients
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016
- Study completionFeb 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 Congenital Mirror MovementsStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Emmanuel ROZE, MD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073604
- Sponsor's protocol ID
- C13-16
- Other IDs
- 2013-A00616-39
- Acronym
- MOMIC2
- Status last verified
- Aug 2016
- First submitted
- 16 Jan 2014
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Welniarz Q, Gallea C, Lamy JC, Meneret A, Popa T, Valabregue R, Beranger B, Brochard V, Flamand-Roze C, Trouillard O, Bonnet C, Bruggemann N, Bitoun P, Degos B, Hubsch C, Hainque E, Golmard JL, Vidailhet M, Lehericy S, Dusart I, Meunier S, Roze E. The supplementary motor area modulates interhemispheric interactions during movement preparation. Hum Brain Mapp. 2019 May;40(7):2125-2142. doi: 10.1002/hbm.24512. Epub 2019 Jan 17.
PubMed 30653778
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rôle de la SMA Dans la préparation Des Mouvements Uni et Bi-manuels: le Paradigme Des Mouvements en Miroir
- ClinicalTrials.gov ID
- NCT02073604
- Acronym / sponsor ID
- MOMIC2 / C13-16
- Conditions
- Congenital Mirror Movements
- Keywords
- Congenital mirror movements, SMA, Movement preparation, Movement lateralization, MRI, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Feb 2014 (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 aim of the project is to study the role of secondary motor area (more precisely the supplementary motor area, or SMA) during unimanual and bimanual voluntary movements externally (cue) or internally (subject's choice) triggered. In that view, we will study 3 experimental groups :
- a group of healthy volunteers (control group)
- the same group of healthy volunteers after a transient inactivation of the SMA (by the aim of repetitive trans cranial magnetic stimulation or TMS)
- a group of patients suffering from congenital mirror movements who are suspected to present a dysfunction of the SMA (according to our previous results) In each of these groups, by the aim of a serial reaction time task, we will study the influence of a SMA stimulation on the excitability of the primary motor cortex (M1) during the preparation of a voluntary movement (unimanual or bimanual). This will allow us to assess the communication between the SMA and M1 during movement preparation. Using the same task in functional imagery, we will study the activation's pattern of primary and secondary motor areas during movement preparation. This multimodal approach should allow us to better understand the synergistic functioning of these different structures involved in movement preparation. An other interesting aspect will be to determine the role of these structures in movement lateralization. Eventually, our results might allow us to precise to role of the motor preparation's dysfunction in the genesis of congenital mirror movements.
In the first place, this study aims at a better understanding of the cerebral physiology of movement preparation (which is not well known) using the mirror movements paradigm as a dysfunction model (according to our previous results). According to our hypothesis, there is a strong link between the SMA and M1 during movement preparation. This hypothesis will be assessed by the use of the same experimental task with combined neurophysiological and neuroimaging approaches, thus increasing the validity of the results obtained.
A secondary aim of this protocol is to precise the role of motor planning dysfunction in patients with congenital mirror movements. A better understanding of the mechanisms responsible for this condition is necessary in a medium-term therapeutic prospect.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Healthy volunteersHealthy volunteers |
| Congenital mirror movements | Other | Other: Congenital mirror movementsPatients presenting with congenital mirror movements |
Who may qualify
- Ages
- 15 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged from 15 years and 3 months to 82 years
- Patients with congenital mirror movements without additional manifestation or malformation
- No contraindications for MRI or TMS study
Key exclusion criteria (3 listed)
- Inability to provide an informed consent
- Simultaneous participation in another clinical trial
- Treatment that modulate cortical excitability (for the TMS part of the study only)
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 |
|---|---|---|
| Healthy volunteersMorphological and functional brain MRI; transcranial magnetic stimulation | Other | Healthy volunteers |
| Congenital mirror movementsMorphological and functional brain MRI; transcranial magnetic stimulation | Other | Congenital mirror movements |
Primary outcome
SMA activation level and connectivity during preparation of unimanual/bimanual movements
Time frame: up to 3 years
1 secondary outcome
SMA activation level and connectivity during preparation of unimanual/bimanual movements in congenital mirror movements patients
Time frame: up to 3 years
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 Aug 2025.
- Results publication: PubMed 30653778Welniarz Q, Gallea C, Lamy JC, Meneret A, Popa T, Valabregue R, Beranger B, Brochard V, Flamand-Roze C, Trouillard O, Bonnet C, Bruggemann N, Bitoun P, Degos B, Hubsch C, Hainque E, Golmard JL, Vidailhet M, Lehericy S, Dusart I, Meunier S, Roze E. The supplementary motor area modulates interhemispheric interactions during movement preparation. Hum Brain Mapp. 2019 May;40(7):2125-2142. doi: 10.1002/hbm.24512. Epub 2019 Jan 17.
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.
Emmanuel ROZE, MD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy volunteers and Congenital mirror movements in people with Congenital Mirror Movements, run by Institut National de la Santé Et de la Recherche Médicale, France 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 3 inclusion and 3 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 Aug 2025. 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. 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?
SMA activation level and connectivity during preparation of unimanual/bimanual movements (time frame: up to 3 years). 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 NCT02073604, 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 29 Aug 2025.