Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02468596
Status:
TERMINATED
Last Update Posted:
2023-02-13
First Post:
2015-03-03
Brief Title:
Use of QTRAC Technique to Measure Axonal Excitability in Anti-MAG Neuropathy
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Axonal Excitability Measured by QTRAC Technique in Patients With Anti-MAG Neuropathy
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXCIMAG
Brief 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
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 diseases 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
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 diseases 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None