- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01750710
Correlation Between Clinical and Electrophysiological Phenotypes in a Population of Patients With Neuropathy Charcot-Marie-Tooth Disease Type 1A (CCA1)
October 8, 2019 updated by: University Hospital, Clermont-Ferrand
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
37
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
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients suffering from CMT 1A neuropathy
Description
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
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
axonal loss
Time Frame: at day 1
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle strength
Time Frame: at day 1
|
at day 1
|
Functional scores
Time Frame: at day 1
|
at day 1
|
Hand testing
Time Frame: at day 1
|
at day 1
|
spatial and temporal parameters of walking
Time Frame: at day 1
|
at day 1
|
Barometric stabilometric podo-static scores
Time Frame: at day 1
|
at day 1
|
Quality of life
Time Frame: at day 1
|
at day 1
|
Fatigue
Time Frame: at day 1
|
at day 1
|
Depression
Time Frame: at day 1
|
at day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
December 1, 2012
Primary Completion (Actual)
April 28, 2016
Study Completion (Actual)
April 28, 2016
Study Registration Dates
First Submitted
November 16, 2012
First Submitted That Met QC Criteria
December 13, 2012
First Posted (Estimate)
December 17, 2012
Study Record Updates
Last Update Posted (Actual)
October 9, 2019
Last Update Submitted That Met QC Criteria
October 8, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Stomatognathic Diseases
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Polyneuropathies
- Disease
- Peripheral Nervous System Diseases
- Tooth Diseases
- Nerve Compression Syndromes
- Charcot-Marie-Tooth Disease
- Hereditary Sensory and Motor Neuropathy
Other Study ID Numbers
- CHU-0128
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.
Clinical Trials on Charcot-Marie-Tooth Type 1A Neuropathy
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University Hospital, Clermont-FerrandActive, not recruitingCharcot-Marie-Tooth Type 1A NeuropathyFrance
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Nationwide Children's HospitalSuspendedCharcot-Marie-Tooth Neuropathy Type 1AUnited States
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Hereditary Neuropathy FoundationRecruitingCharcot-Marie-Tooth Disease | Charcot-Marie-Tooth Disease, Type IA | Charcot-Marie-Tooth Disease Type 2A | Charcot-Marie-Tooth | Charcot-Marie-Tooth Disease, Type IB | Charcot-Marie-Tooth Disease Type 2 | Charcot-Marie-Tooth Disease, Type 2C | Charcot-Marie-Tooth Disease Type 2A2B | Charcot-Marie-Tooth... and other conditionsUnited States
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Pharnext S.C.A.Premier Research Group plc; Eurofins Optimed; Synteract HCR (Syneos Health); Gr... and other collaboratorsActive, not recruitingCharcot-Marie-Tooth Disease, Type IAUnited States, Belgium, Canada, France, Netherlands, Spain, United Kingdom
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Pharnext SACompletedCharcot-Marie-Tooth Disease | Hereditary Neuropathy With Liability to Pressure Palsies | Genetic DisordersFrance
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University College, LondonUniversity of IowaUnknownCharcot-Marie-Tooth Disease, Type IA | Charcot-Marie-Tooth Disease Type 2A | Charcot-Marie-Tooth Disease, Type IB | Charcot-Marie-Tooth Disease, Type XUnited Kingdom
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ENCellRecruitingCharcot-Marie-Tooth Disease Type 1AKorea, Republic of