NCT02073604

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

January 16, 2014

Last Update Submit

August 22, 2025

Conditions

Keywords

Congenital mirror movementsSMAMovement preparationMovement lateralizationMRITranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • SMA activation level and connectivity during preparation of unimanual/bimanual movements

    up to 3 years

Secondary Outcomes (1)

  • SMA activation level and connectivity during preparation of unimanual/bimanual movements in congenital mirror movements patients

    up to 3 years

Study Arms (2)

Healthy volunteers

OTHER

Healthy volunteers

Other: Healthy volunteers

Congenital mirror movements

OTHER

Patients presenting with congenital mirror movements

Other: Congenital mirror movements

Interventions

Morphological and functional brain MRI; transcranial magnetic stimulation

Healthy volunteers

Morphological and functional brain MRI; transcranial magnetic stimulation

Congenital mirror movements

Eligibility Criteria

Age15 Years - 82 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75013, France

Location

Related Publications (1)

  • Chole RA. Meatoplasty using inferiorly based island pedicle flap for congenital aural atresia. Laryngoscope. 1983 Jul;93(7):954-5. doi: 10.1288/00005537-198307000-00025. No abstract available.

    PMID: 6865634BACKGROUND

MeSH Terms

Interventions

Mirror Movement Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Emmanuel ROZE, MD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

February 27, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 29, 2025

Record last verified: 2016-08

Locations