Trial record 4 of 341 for:    Charcot-Marie-Tooth Disease

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

This study is not yet open for participant recruitment.
Verified December 2012 by University Hospital, Clermont-Ferrand
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
  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:


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

Primary Outcome Measures:
  • axonal loss [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Muscle strength [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Functional scores [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Hand testing [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • spatial and temporal parameters of walking [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Barometric stabilometric podo-static scores [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Fatigue [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Depression [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Tooth Diseases
Demyelinating Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Stomatognathic Diseases
Substance-Related Disorders
Hereditary Sensory and Motor Neuropathy
Polyneuropathies
Neurologic Manifestations
Neurotoxicity Syndromes
Nervous System Malformations
Congenital Abnormalities
Signs and Symptoms
Poisoning

ClinicalTrials.gov processed this record on April 17, 2014