Intermittent Hypoxia-Induced Motor Plasticity in Sub-Acute Spinal Cord Injury

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, diminishing breathing capacity and airway defense (e.g., cough). Indeed, respiratory impairment is a leading cause of infection, re-hospitalization and death after SCI. There is a critical need for new strategies to restore breathing ability and airway defense in people with SCI. Acute intermittent hypoxia (AIH) - repetitive exposure to brief episodes of low inspired oxygen - is a promising strategy to restore breathing capacity by promoting spinal neuroplasticity. Exciting outcomes in \>12 SCI trials completed to date demonstrate that AIH improves human respiratory and limb function. Unfortunately, \ 40% of individuals exhibit minimal response to AIH, making it essential to 1) optimize AIH protocols to maximize functional benefits; and 2) identify genetic biomarkers distinguishing those most/least likely to benefit from AIH-based treatments. The purpose of the pilot study, to be conducted in a small sample of participants with sub-acute SCI (1 to 6 months post injury), is to preliminarily compare the immediate effects of two intermittent hypoxia protocols. Since AIH-induced plasticity may be induced via serotonin or adenosine-driven mechanisms and these pathways compete and inhibit each other, each protocol favors a distinct mechanistic pathway. The long-term objective is to test the hypothesis that a longer duration (i.e., augmented) hypoxia protocol, favoring adenosine mechanisms, enhances respiratory motor plasticity more than an AIH protocol targeting serotonin mechanisms (low O2 + CO2) in people with sub-acute SCI. Since an individual's genetics can influence the response to rehabilitation, investigators are also preliminarily investigating how certain genes are related to breathing changes after these treatments. Data acquired through this pilot study will be used to inform a larger, more definitive clinical trial and will contribute to estimations of the magnitude and direction of effects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Adults 18-70 years of age

• Sub-acute incomplete SCI 1 to 6 months after injury, at or below C1-T6 Incomplete SCI based on residual sensory and motor function below the level of the injury or injury classification of B, C, D at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI.

⁃ OR- Sub-acute complete SCI 1 to 6 months after injury at or below C4-T6 Complete SCI based on the absence of residual sensory or motor function below the level of injury or injury classification of A at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI.

• Medically stable with physician clearance

• SCI due to non-progressive etiology

Locations
United States
Florida
Brooks Rehabilitation Clinical Research Center
RECRUITING
Jacksonville
Contact Information
Primary
Emily J Fox, PT, DPT, MHS, PhD
ejfox@phhp.ufl.edu
904-742-2500
Backup
Hannah J Snyder, M.S.
Hannah.Snyder@brooksrehab.org
904-345-6910
Time Frame
Start Date: 2025-05-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 10
Treatments
Experimental: Sham, aAIH, AIHH
Participants will complete three separate single-session testing days. Baseline testing will be performed, then on each day, participants will receive interventions in the following order: Sham, aAIH, and AIHH. Post-testing will occur after each intervention.
Experimental: Sham, AIHH, aAIH
Participants will complete three separate single-session testing days. Baseline testing will be performed, then on each day, participants will receive interventions in the following order: Sham, AIHH, and aAIH. Post-testing will occur after each intervention.
Related Therapeutic Areas
Sponsors
Leads: University of Florida
Collaborators: Brooks Rehabilitation

This content was sourced from clinicaltrials.gov