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

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

Tracking Information

• First Submitted Date: February 4, 2010
• First Posted Date: February 24, 2010
• Last Update Posted Date: February 24, 2016
• Study Start Date: February 2010
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification PROJET " MOMIC "
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 23, 2016): 40
• Original Estimated Enrollment (submitted: February 23, 2010): 45
• Actual Study Completion Date: July 2011
• Actual Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 11 Years to 82 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01075061
• Other Study ID Numbers: C09-06; 2009-A00490-57 ( Registry Identifier: IDRCB )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• Study Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Not Provided

Investigators

• 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