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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT01750710

First received: November 16, 2012

Last updated: December 13, 2012

Last verified: December 2012

History of Changes

Purpose

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
Charcot-Marie-Tooth Type 1A Neuropathy


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Charcot-Marie-Tooth Disease Tooth Disorders

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsy Roussy Levy Syndrome Charcot-Marie-Tooth Disease Type 1 Charcot-Marie-Tooth Disease Type 1A

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

axonal loss [ Time Frame: at day 1 ]

Secondary Outcome Measures:

Muscle strength [ Time Frame: at day 1 ]
Functional scores [ Time Frame: at day 1 ]
Hand testing [ Time Frame: at day 1 ]
spatial and temporal parameters of walking [ Time Frame: at day 1 ]
Barometric stabilometric podo-static scores [ Time Frame: at day 1 ]
Quality of life [ Time Frame: at day 1 ]
Fatigue [ Time Frame: at day 1 ]
Depression [ Time Frame: at day 1 ]


Estimated Enrollment:	60
Study Start Date:	December 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	November 16, 2012
Last Updated:	December 13, 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 Charcot-Marie-Tooth Disease Nerve Compression Syndromes Hereditary Sensory and Motor Neuropathy Tooth Diseases Neuromuscular Diseases Nervous System Diseases	Nervous System Malformations Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Polyneuropathies Congenital Abnormalities Genetic Diseases, Inborn Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 25, 2017

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