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Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification PROJET " MOMIC " (MOMIC)

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ClinicalTrials.gov Identifier: NCT01075061
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date  ICMJE February 4, 2010
First Posted Date  ICMJE February 24, 2010
Last Update Posted Date February 24, 2016
Study Start Date  ICMJE February 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
- To unravel the pathophysiology of congenital mirror movements - To identify a locus and candidate genes associated with CMM [ Time Frame: 08/2011 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2010)
- To study patients with Kallmann syndrome and associated MM based on the same methods and hypothesis [ Time Frame: 08/2011 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification PROJET " MOMIC "
Official Title  ICMJE Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification : MOMIC
Brief Summary Mirror movements are involuntary, symmetrical and simultaneous movements occurring on one side of the body that accompany controlateral voluntary movements. Congenital mirror movements (CMM) are characterized by childhood onset and the absence of additional manifestations. The aim of this study is to unravel the pathophysiology of the CMM that remains poorly elucidated. The combination of imaging studies and neurophysiological studies using transcranial magnetic stimulation in a homogeneous and relatively large group of patient is likely to allow us to better understand the underlying pathophysiology of the disorder. Using a linkage analysis approach we will try to identify a locus associated with CMM and related candidate genes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: healthy volunteers
    morphological and functional brain MRI; transcranial magnetic stimulation
  • Other: Kallmann
    morphological and functional brain MRI; transcranial magnetic stimulation
  • Other: Congenital Mirror Movement
    morphological and functional brain MRI; transcranial magnetic stimulation
Study Arms  ICMJE
  • healthy volunteers
    healthy volunteers
    Intervention: Other: healthy volunteers
  • Kallmann
    Kallmann syndrome patients
    Intervention: Other: Kallmann
  • Congenital Mirror Movement
    patients with CMM
    Intervention: Other: Congenital Mirror Movement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2010)
45
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged from 11 to 82 years
  • Members of the family of interest displaying mirror movements or being obligatory asymptomatic carrier, without additional manifestation or malformation; or patient with genetically proven Kallmann syndrome and mirror movements.
  • No contraindication 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 82 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01075061
Other Study ID Numbers  ICMJE C09-06
2009-A00490-57 ( Registry Identifier: IDRCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emmanuel ROZE, MD Institut National de la Santé Et de la Recherche Médicale, France
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP