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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
  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   (Adult, Senior)
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
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

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
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
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:
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
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on December 02, 2016