- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01075061
Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification PROJET " MOMIC " (MOMIC)
February 23, 2016 updated by: Institut National de la Santé Et de la Recherche Médicale, France
Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification : MOMIC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- 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
-
-
-
Paris, France, 75013
- Fédération des Maladies du Système Nerveux, Hôpital Pitié Salpétrière
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 82 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
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 |
Intervention / Treatment |
---|---|
Other: healthy volunteers
|
morphological and functional brain MRI; transcranial magnetic stimulation
|
Other: Kallmann
Kallmann syndrome patients
|
morphological and functional brain MRI; transcranial magnetic stimulation
|
Other: Congenital Mirror Movement
patients with CMM
|
morphological and functional brain MRI; transcranial magnetic stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- To unravel the pathophysiology of congenital mirror movements - To identify a locus and candidate genes associated with CMM
Time Frame: 08/2011
|
08/2011
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- To study patients with Kallmann syndrome and associated MM based on the same methods and hypothesis
Time Frame: 08/2011
|
08/2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Emmanuel ROZE, MD, Institut National de la Santé Et de la Recherche Médicale, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 4, 2010
First Submitted That Met QC Criteria
February 23, 2010
First Posted (Estimate)
February 24, 2010
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- C09-06
- 2009-A00490-57 (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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