Genetic Biomarkers of Intermittent Hypoxia-Induced Respiratory Motor Plasticity in Chronic SCI

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

Acute intermittent hypoxia (AIH) involves brief (1 min), repeated episodes (\ 15) of breathing low oxygen air to stimulate spinal neuroplasticity. Animal and human studies show that AIH improves motor function after spinal cord injury, particularly with slightly increased carbon dioxide (hypercapnic AIH; AIHH) and task-specific training. Using a double blind cross-over design, the study will test whether AIHH improves breathing more than AIH and whether specific genetic variations are related to individuals' intervention responses.

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

• Adults 18-70 years of age

• Chronic incomplete SCI ≥ 1 year at or below C1-T12

‣ 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- Chronic complete SCI ≥1 year at or below C4-T12

⁃ 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

• 20% impairment in maximal inspiratory, maximal expiratory pressure generation, or both relative to normative values

Locations
United States
Florida
Brooks Rehabilitation
RECRUITING
Jacksonville
Contact Information
Primary
Emily J Fox, PT, MHS, PhD
ejfox@phhp.ufl.edu
904-742-2500
Backup
Hannah Snyder, M.S.
Hannah.snyder@brooksrehab.org
904-345-6910
Time Frame
Start Date: 2023-12-21
Estimated Completion Date: 2027-09
Participants
Target number of participants: 62
Treatments
Experimental: Single-session testing days
Participants will complete three separate single-session testing days. Baseline testing will be performed, then on each day, participants will receive AIH, AIHH, and sham AIH in random order. Post-testing will occur after each intervention.
Experimental: Respiratory strength training blocks
Participants will complete three separate respiratory strength training blocks. In each block, participants will receive 5 days of AIH, 5 days of AIHH, and 5 days of sham AIH in random order, followed by respiratory strength training. Each block will include 5 days of intervention and training, and post-testing 1, 3, and 7 days after intervention and training has concluded.
Related Therapeutic Areas
Sponsors
Collaborators: U.S. Army Medical Research Acquisition Activity
Leads: University of Florida

This content was sourced from clinicaltrials.gov