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Correlation Between Clinical and Electrophysiological Phenotypes in a Population of Patients With Neuropathy Charcot-Marie-Tooth Disease Type 1A (CCA1)

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ClinicalTrials.gov Identifier: NCT01750710
Recruitment Status : Unknown
Verified December 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This exploratory cross-sectional study proposes, firstly, to objectify in a population of Charcot-Marie-Tooth disease type 1A (CMT 1A)if there is a correlation between the recording of electrical parameters and upper limb muscle strength of the thigh and in a second step, to seek a relationship between the measured parameters.

Condition or disease
Charcot-Marie-Tooth Type 1A Neuropathy

Detailed Description:

Patients suffering from CMT 1A neuropathy will be invited to go through a series of tests such as:

  • Electromyography
  • Isokinetic test
  • Podiatric assessment
  • Functional evaluations: Hand dexterity, limbs muscles strength
  • Quality of life assessment with questionnaires

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Time Perspective: Cross-Sectional
Official Title: Correlation Between Clinical and Electrophysiological Phenotypes in a Population of Patients With Neuropathy Charcot-Marie-Tooth Disease Type 1A
Study Start Date : December 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013


Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. axonal loss [ Time Frame: at day 1 ]

Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: at day 1 ]
  2. Functional scores [ Time Frame: at day 1 ]
  3. Hand testing [ Time Frame: at day 1 ]
  4. spatial and temporal parameters of walking [ Time Frame: at day 1 ]
  5. Barometric stabilometric podo-static scores [ Time Frame: at day 1 ]
  6. Quality of life [ Time Frame: at day 1 ]
  7. Fatigue [ Time Frame: at day 1 ]
  8. Depression [ Time Frame: at day 1 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from CMT 1A neuropathy
Criteria

Inclusion Criteria:

  • Patients older than 18 years
  • Diagnosis of Charcot Marie Tooth disease, type 1A confirmed by molecular biology (duplication 17.p11.2)
  • Listening and written French
  • Agreement after written information, clear and honest about the purpose of the study, the nature of the tests and their possible side effects or bothersome.
  • Strength of the quadriceps superior to 2/5 MMT MRC

Exclusion Criteria:

  • Presence of other neurological comorbidity
  • Presence of coronary artery disease unstabilized
  • Peripheral neuropathy of other causes: diabetes, monoclonal gammopathy, malignancy, solid cancer, systemic autoimmune disease (lupus, Sjögren's disease, Wegener sarcoidosis ...), infectious disease (viral hepatitis, HIV ...), drugs known to be responsible for iatrogenic neuropathy.
  • Gait trouble of other origin
  • Patients unable to give their consent.
  • Intellectual deficit that does not allow to comply with tests
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750710


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Emmanuel COUDEYRE University Hospital, Clermont-Ferrand
More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01750710     History of Changes
Other Study ID Numbers: CHU-0128
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by University Hospital, Clermont-Ferrand:
Charcot-Marie-Tooth disease type 1A neuropathy
Isokinetic
Electromyography
Walking

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Tooth Diseases
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Neuromuscular Diseases
Nervous System Diseases
Stomatognathic Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Nervous System Malformations
Polyneuropathies
Congenital Abnormalities