Role of the SMA During Unimanual and Bimanual Movements Preparation: the Mirror Movements Paradigm (MOMIC2)

August 22, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Fédération des Maladies du Système Nerveux, Hôpital Pitié Salpétrière Paris, France 75013

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 82 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Healthy volunteers
Other: Healthy volunteers
Morphological and functional brain MRI; transcranial magnetic stimulation
Other: Congenital mirror movements
Patients presenting with congenital mirror movements
Other: Congenital mirror movements
Morphological and functional brain MRI; transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
SMA activation level and connectivity during preparation of unimanual/bimanual movements
Time Frame: up to 3 years
up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
SMA activation level and connectivity during preparation of unimanual/bimanual movements in congenital mirror movements patients
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emmanuel ROZE, MD, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C13-16
  • 2013-A00616-39 (Registry Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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