- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05848778
Non-invasive Therapy to Drive Nerve Regeneration
Novel Non-invasive Therapy to Drive Robust and Sustained Peripheral Nerve Regeneration
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Peripheral nerve injuries are frequent and disabling, often with irreversible consequences. Injured sensory and motor neurons induce cellular and molecular events we refer to as the intrinsic repair program, linked to their regeneration capacity. Regrettably, regeneration of these nerves is challenging. Issues include whether the intrinsic repair program is robust enough, or is sustained long enough, to ensure repair over long distances. This can result in incomplete repair and/or pain states. The investigators will exploit acute intermittent hypoxia (intermittent periods of reduced oxygen), a novel treatment to condition/prime peripheral nerves and induce an enhanced intrinsic repair program. Acute intermittent hypoxia is non-invasive and has a systemic effect which is a major advantage in cases where there are multiple nerve injured in a widespread distribution, as opposed to electrical stimulation that only impacts the individual nerve stimulated. However, the full potential of acute intermittent hypoxia in nerve repair remains unknown. This will be a Phase I randomized control trial of carpal tunnel syndrome associated with severe median nerve compression/injury. This is designed to test the hypothesis that acute intermittent hypoxia before and/or after nerve decompression will result in more effective nerve regeneration and restoration of function.
Methods:
Using a double blinded randomized controlled trial design, we will recruit 80 adult patients (50% male; 50% female) >18 yrs old with severe carpal tunnel syndrome.
Statistical analysis:
Distribution of the outcome data will be analyzed using the Shapiro-Wilk test. For parameters that are normally distributed, differences between the groups will be compared using 2-way analysis of variance (ANOVA) with time and treatment allocation being the independent factors. When a statistically significant difference (p<0.05) is found, post hoc testing will be done using the Tukey test. For data that is not normally distribution, the Kruskal-Wallis test will be used instead, followed by post hoc analysis with Dunn's test when a significant difference is found. Sample size estimation - Assuming that AIH has a modest treatment effect size of 0.6 compared to the Normoxia control group, with type I error set at 0.05 and type II error at 0.80, appropriately 20 subjects are needed in each group to provide sufficient power for the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
i) sensory impairments including numbness and pain; ii) nocturnal awakening by these symptoms; iii) weakness and wasting of the thenar musculature and, iv) loss of hand dexterity. v) Motor unit loss greater than 2 SD below the mean for the age group
Exclusion Criteria:
i) Chronic lung or cardiac disease ii) Other nerve disorders, previous carpal tunnel release or systemic illness including diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Acute Intermittent Hypoxia
Patients with hand weakness and numbness secondary to median nerve entrapment and scheduled for carpal tunnel release surgery will be randomly assigned to receive acute intermittent hypoxia
|
The acute intermittent hypoxia protocol will consist of 15 cycles of 1.5 min of inspiring ambient air (21% O2) alternating with 1.5 min of hypoxic air (9% O2)
|
Placebo Comparator: Normoxia control
Patients with hand weakness and numbness secondary to median nerve entrapment and scheduled for carpal tunnel release surgery will be randomly assigned to receive normoxia
|
The normoxia protocol will consist of 15 cycles of 3 min of inspiring ambient air (21% O2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor unit number estimation
Time Frame: At 3, 6 and 12 months compared to baseline
|
The number of motor units in the median innervated thenar muscles.
|
At 3, 6 and 12 months compared to baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Two point discrimination
Time Frame: At 3, 6 and 12 months compared to baseline
|
Testing the A-beta sensory fibers using the Dellon-MacKinnon Disk
|
At 3, 6 and 12 months compared to baseline
|
Fine touch sensation
Time Frame: At 3, 6 and 12 months compared to baseline
|
Testing the A-beta fibers using Semmes-Weinstein monofilaments
|
At 3, 6 and 12 months compared to baseline
|
Quantitative sensory testing
Time Frame: At 3, 6 and 12 months compared to baseline
|
Cold threshold (A-beta fibers) and pain threshold (C fibers) using CASE IV quantitative sensory testing equipment
|
At 3, 6 and 12 months compared to baseline
|
Boston Carpal Tunnel Symptom Severity
Time Frame: At 3, 6 and 12 months compared to baseline
|
Self administered questionnaire
|
At 3, 6 and 12 months compared to baseline
|
Moberg Pick-up Test
Time Frame: At 3, 6 and 12 months compared to baseline
|
To measure hand dexterity and functional performance
|
At 3, 6 and 12 months compared to baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00128891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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