Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294821
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-21
Brief Title:
4AP to Delay Carpal Tunnel Release CTR
Sponsor:
John Elfar
Organization:
University of Arizona
Study Overview
Official Title:
4-Aminopyridine to Delay Carpal Tunnel Release
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTR
Brief Summary:
The investigators have found recent promising data supporting the use of a currently FDA approved drug 4-aminopyridine in the treatment of nerve injury including compression neuropathy The purpose of this research is determine whether 4-aminopyridine can delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery
Detailed Description:
Carpal tunnel syndrome affects somewhere between 3 and 10 of the Unites States population Symptoms associated with this disorder include numbness and tingling in the radial three digits of the hand These symptoms often cause sleeplessness They have been attributed to work related activities The diagnosis of carpal tunnel syndrome is made clinically Several confirmatory tests exist in the setting of carpal tunnel syndrome In the United States the gold standard diagnostic for carpal tunnel syndrome is electrodiagnostic evaluation This notwithstanding recent literature suggests that other diagnostic methods including ultrasound evaluation of the median nerve at the carpal tunnel as well as clinical diagnostic criteria are sufficient to adequately and specifically diagnose carpal tunnel syndrome
Several treatments exist for carpal tunnel syndrome Treatment range from non-operative braces or positional movements Moving on to intervention treatments there are several injections that have been used to treat carpal tunnel syndrome Carpal Tunnel Syndrome is most definitively and completely treated by surgical release of the median nerve at the carpal tunnel Surgical releases themselves have been performed under a variety of techniques from formal median nerve exploration to mini-open release as well endoscopic release Resolution of symptoms after carpal tunnel release has been regarded as the gold standard to which other treatments can be compared
Several registries of compression neuropathy patients have been compiled These registries reveal that non-invasive assessment with standardize validated questionnaires can be used to measure the progression of symptomology and the resolution of treatment Given the history and wealth of experience in the diagnosis and treatment in this condition its natural to ask are there non-operative pharmacological treatments that may delay or remove the need for carpal tunnel release surgery Certainly the comparison to surgical decompression as the gold standard is desirable
More research is needed to evaluate the role of 4-aminopyridine 4AP in the treatment of compression neuropathy The investigational treatment will be used to test the hypothesis that 4AP improves symptoms and electrodiagnostic parameters in carpal tunnel syndrome patients
Several treatments exist for carpal tunnel syndrome Treatment range from non-operative braces or positional movements Moving on to intervention treatments there are several injections that have been used to treat carpal tunnel syndrome Carpal Tunnel Syndrome is most definitively and completely treated by surgical release of the median nerve at the carpal tunnel Surgical releases themselves have been performed under a variety of techniques from formal median nerve exploration to mini-open release as well endoscopic release Resolution of symptoms after carpal tunnel release has been regarded as the gold standard to which other treatments can be compared
Several registries of compression neuropathy patients have been compiled These registries reveal that non-invasive assessment with standardize validated questionnaires can be used to measure the progression of symptomology and the resolution of treatment Given the history and wealth of experience in the diagnosis and treatment in this condition its natural to ask are there non-operative pharmacological treatments that may delay or remove the need for carpal tunnel release surgery Certainly the comparison to surgical decompression as the gold standard is desirable
More research is needed to evaluate the role of 4-aminopyridine 4AP in the treatment of compression neuropathy The investigational treatment will be used to test the hypothesis that 4AP improves symptoms and electrodiagnostic parameters in carpal tunnel syndrome patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None