Non-invasive Therapy to Drive Nerve Regeneration

NCT05848778 | Enrolling By Invitation

• 1 other identifier: Pro00128891
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral nerve injuries are common and often associated with poor outcomes including incomplete repair, debilitating pain states and compromised function. Although nerve regeneration can be enhanced by brief electrical nerve stimulation at the time of or before surgical repair in rodents and humans, this approach is invasive. Acute intermittent hypoxia, breathing alternate cycles of regular air and air with \~50% normal oxygen levels (11% O2) is an emerging, promising non-invasive therapy promoting respiratory and non-respiratory muscle function in spinal cord injured rats and humans. Because the entire body is exposed to this therapy, it has the potential to globally impact the nervous system beyond just controlling respiratory and leg function in spinal cord injured patients. Thus, the investigators hypothesized that an acute intermittent hypoxia paradigm similar to that used for spinal cord repair will improve peripheral nerve repair in a manner akin to electrical stimulation, including its impact on expression of regeneration-associated proteins - a predictor of nerve growth states. In recent studies the investigators found this to be the case and now propose to continue these promising studies by performing a pilot clinical trial evaluating this form of treatment on patients with compromised hand function due to severe carpal tunnel syndrome. The goal is to improve nerve repair outcomes in the least invasive and optimal manner.

Conditions

Peripheral Nerve Injuries

Outcome Measures

Primary Outcomes (1)

• Motor unit number estimation

  The number of motor units in the median innervated thenar muscles.

  At 3, 6 and 12 months compared to baseline

Secondary Outcomes (5)

• Two point discrimination

  At 3, 6 and 12 months compared to baseline

• Fine touch sensation

  At 3, 6 and 12 months compared to baseline

• Quantitative sensory testing

  At 3, 6 and 12 months compared to baseline

• Boston Carpal Tunnel Symptom Severity

  At 3, 6 and 12 months compared to baseline

• Moberg Pick-up Test

  At 3, 6 and 12 months compared to baseline

Study Arms (2)

Acute Intermittent Hypoxia

ACTIVE COMPARATOR

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

Device: Acute Intermittent Hypoxia

Normoxia control

PLACEBO COMPARATOR

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

Device: Normoxia

Interventions

Acute Intermittent Hypoxia DEVICE

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)

Acute Intermittent Hypoxia

Normoxia DEVICE

The normoxia protocol will consist of 15 cycles of 3 min of inspiring ambient air (21% O2)

Normoxia control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• i) Chronic lung or cardiac disease ii) Other nerve disorders, previous carpal tunnel release or systemic illness including diabetes

Sponsors & Collaborators

• University of Alberta: lead
• Royal Alexandra Hospital: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will investigate AIH's potential to condition and promote enhanced repair in a Phase I randomized control trial (RCT) of carpal tunnel syndrome (CTS) associated with severe median nerve compression/injury. We predict AIH will have better outcomes than current ES strategies and we aim to non-invasively condition/prime the IRP in compressed nerves by AIH treatment prior to nerve decompression and/or post-nerve decompression.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 8, 2023
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)