Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy)EXCIMAGNCT02468596
Use of QTRAC Technique to Measure Axonal Excitability in Anti-MAG Neuropathy
A study testing QTRAC assessment and Clinical assessment of peripheral nerve function in people with Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy), run by Fondation Ophtalmologique Adolphe de Rothschild at 8 sites in France.
Trial summary
The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal excitability, using computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy)
- What is being tested?
- QTRAC assessment and Clinical assessment of peripheral nerve function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 8 sitesFrance
- Study dates
- Nov 2014to Feb 2022
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anti-MAG neuropathy (peripheral neuropathy and IgM monoclonal gammopathy with anti-MAG activity superior to 1000 BTU)
Who cannot join
- current treatment with a medication that modifies peripheral nerve excitability (e.g. anticonvulsivants)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Service de Neurologie Hôpital Pellegrin
Bordeaux, 33076
Service de Neurologie Hôpital Henry Mondor
Créteil, 94000
Département de Neurologie Hôpital Roger Salengro
Lille, 59037
service de neurologie, CHU Limoges
Limoges
Service ENMG et pathologies Neuro Musculaires, Hôpital Neurologique Pierre Wertheimer
Lyon, 69677
Laboratoire des explorations fonctionnelles, Hôtel Dieu
Nantes, 44093
Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
Service de Neurologie CHU St Etienne
Saint-Etienne, 42055
About this study
Official title: Axonal Excitability Measured by QTRAC Technique in Patients With Anti-MAG Neuropathy
The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal excitability, using computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve.
Because of its high sensitivity to small changes in axonal excitability, QTRAC may help improve the follow-up of patients suffering from peripheral neuropathy caused by anti-myelin-associated-glycoprotein antibodies (anti-MAG neuropathy), as axonal excitability is early affected in this disease.
Read more
The main aim of the study is to compare QTRAC results in anti-MAG neuropathy patients, with QTRAC results in healthy persons (matched for sex and age).
A secondary aim is to determine whether or not the disease's clinical severity (measured by quantitative clinical scores) is correlated with the results of the QTRAC and could be predicted by a model based on the several parameters measured in the QTRAC exploration.
100 anti-MAG neuropathy patients will undergo a QTRAC exploration and a thorough neurological examination with clinical scoring. The results will be compared with data (matched by sex and age) from the reference database on healthy subjects, that is provided with the QTRAC software.
The investigators expect to prove that QTRAC results are modified in anti-MAG neuropathy patients, and that the clinical severity of the disease can be predicted by a combination of QTRAC-measured parameters.
- Being tested
- QTRAC assessment, Clinical assessment of peripheral nerve function
- Keywords
- Axonal excitability, Neuropathy, QTRAC, anti-MAG, Electrophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QTRAC assessmentOther
Computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve
Clinical assessment of peripheral nerve functionOther
Clinometric assessment using RT-MRC, Martin vigirometer, RT-mISS, T25W, 9 hole peg test, and ataxia scale
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients suffering from anti-MAG neuropathy Receives: Other: QTRAC assessment; Other: Clinical assessment of peripheral nerve function |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTRAC-measured refractority of the median nerve
the duration of the refractory period of the median nerve (expressed in milliseconds) is automatically measured by the QTRAC system, using a series of double electrical stimulations (the first being supra-maximal and the second, sub-maximal) and progressively increasing the time between the two stimuli.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2019
- Study completionFeb 2022
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy)Studies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468596
- Sponsor's protocol ID
- AGN_2014-20
- Acronym
- EXCIMAG
- Status last verified
- Feb 2023
- First submitted
- 3 Mar 2015
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axonal Excitability Measured by QTRAC Technique in Patients With Anti-MAG Neuropathy
- ClinicalTrials.gov ID
- NCT02468596
- Acronym / sponsor ID
- EXCIMAG / AGN_2014-20
- Keywords
- Axonal excitability, Neuropathy, QTRAC, anti-MAG, Electrophysiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 11 Jun 2015 (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.
The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal excitability, using computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve.
Because of its high sensitivity to small changes in axonal excitability, QTRAC may help improve the follow-up of patients suffering from peripheral neuropathy caused by anti-myelin-associated-glycoprotein antibodies (anti-MAG neuropathy), as axonal excitability is early affected in this disease.
The main aim of the study is to compare QTRAC results in anti-MAG neuropathy patients, with QTRAC results in healthy persons (matched for sex and age).
A secondary aim is to determine whether or not the disease's clinical severity (measured by quantitative clinical scores) is correlated with the results of the QTRAC and could be predicted by a model based on the several parameters measured in the QTRAC exploration.
100 anti-MAG neuropathy patients will undergo a QTRAC exploration and a thorough neurological examination with clinical scoring. The results will be compared with data (matched by sex and age) from the reference database on healthy subjects, that is provided with the QTRAC software.
The investigators expect to prove that QTRAC results are modified in anti-MAG neuropathy patients, and that the clinical severity of the disease can be predicted by a combination of QTRAC-measured parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: QTRAC assessment, Other: Clinical assessment of peripheral nerve functionPatients suffering from anti-MAG neuropathy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anti-MAG neuropathy (peripheral neuropathy and IgM monoclonal gammopathy with anti-MAG activity superior to 1000 BTU)
Key exclusion criteria (1 listed)
- current treatment with a medication that modifies peripheral nerve excitability (e.g. anticonvulsivants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QTRAC assessmentComputerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve | Other | Patients |
| Clinical assessment of peripheral nerve functionClinometric assessment using RT-MRC, Martin vigirometer, RT-mISS, T25W, 9 hole peg test, and ataxia scale | Other | Patients |
Primary outcome
QTRAC-measured refractority of the median nerve
Time frame: Inclusion
the duration of the refractory period of the median nerve (expressed in milliseconds) is automatically measured by the QTRAC system, using a series of double electrical stimulations (the first being supra-maximal and the second, sub-maximal) and progressively increasing the time between the two stimuli.
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QTRAC assessment and Clinical assessment of peripheral nerve function in people with Peripheral Neuropathy Associated With Anti-myelin Associated Glycoprotein Antibodies (Anti-MAG Neuropathy), run by Fondation Ophtalmologique Adolphe de Rothschild at 8 sites 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
QTRAC-measured refractority of the median nerve (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2023.