Charcot-Marie-Tooth Type 1A NeuropathyCCA1NCT01750710
Correlation Between Clinical and Electrophysiological Phenotypes in a Population of Patients With Neuropathy Charcot-Marie-Tooth Disease Type 1A
An observational study of Charcot-Marie-Tooth Type 1A Neuropathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Charcot-Marie-Tooth Type 1A Neuropathy
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to 28 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from CMT 1A neuropathy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Charcot-Marie-Tooth Type 1A Neuropathy
- Keywords
- Charcot-Marie-Tooth disease type 1A neuropathy, Isokinetic, Electromyography, Walking
- Medical subject headings
- Charcot-Marie-Tooth Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
axonal loss
Measured: at day 1
Secondary outcomes (8)
Muscle strength
Measured: at day 1
Functional scores
Measured: at day 1
Hand testing
Measured: at day 1
spatial and temporal parameters of walking
Measured: at day 1
Barometric stabilometric podo-static scores
Measured: at day 1
Quality of life
Measured: at day 1
Fatigue
Measured: at day 1
Depression
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completion28 Apr 2016
- Study completion28 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Charcot-Marie-Tooth Type 1A NeuropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel COUDEYRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750710
- Sponsor's protocol ID
- CHU-0128
- Acronym
- CCA1
- Status last verified
- Oct 2019
- First submitted
- 16 Nov 2012
- Last updated
- 9 Oct 2019
- Results posted
- No
Publications
Bihel L, Reynaud V, Givron P, Clavelou P, Cornut-Chauvinc C, Pereira B, Thomas E, Taithe F, Coudeyre E. Foot Function Index: A Promising Questionnaire for Individuals With Charcot-Marie-Tooth Disease Type 1A. Arch Phys Med Rehabil. 2019 Dec;100(12):2403-2406. doi: 10.1016/j.apmr.2019.06.003. Epub 2019 Jun 28.
PubMed 31255638
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Clinical and Electrophysiological Phenotypes in a Population of Patients With Neuropathy Charcot-Marie-Tooth Disease Type 1A
- ClinicalTrials.gov ID
- NCT01750710
- Acronym / sponsor ID
- CCA1 / CHU-0128
- Conditions
- Charcot-Marie-Tooth Type 1A Neuropathy
- Keywords
- Charcot-Marie-Tooth disease type 1A neuropathy, Isokinetic, Electromyography, Walking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- 28 Apr 2016 (actual)
- Study completion
- 28 Apr 2016 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from CMT 1A neuropathy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
axonal loss
Time frame: at day 1
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 31255638Bihel L, Reynaud V, Givron P, Clavelou P, Cornut-Chauvinc C, Pereira B, Thomas E, Taithe F, Coudeyre E. Foot Function Index: A Promising Questionnaire for Individuals With Charcot-Marie-Tooth Disease Type 1A. Arch Phys Med Rehabil. 2019 Dec;100(12):2403-2406. doi: 10.1016/j.apmr.2019.06.003. Epub 2019 Jun 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel COUDEYRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Charcot-Marie-Tooth Type 1A Neuropathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
axonal loss (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.