Spinal Cord Injuries Clinical Trial
Official title:
Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury
Verified date | December 2021 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. This information may be useful in advancing rehabilitation for people with spinal cord injuries.
Status | Completed |
Enrollment | 17 |
Est. completion date | September 1, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion criteria: 1. Male or female, ages 18-65 2. Greater than 6 months post-spinal cord injury 3. Spinal cord injury affecting segments between C4-T12 4. No other known neurological disorders 5. Able to provide informed consent 6. no severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments. Exclusion criteria: 1. Presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia 2. Severe, untreated bladder or urinary tract infection 3. Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments 4. Women who report being pregnant or test positive on a pregnancy test |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
United States | Brooks Rehabilitation | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Gonzalez-Rothi EJ, Lee KZ, Dale EA, Reier PJ, Mitchell GS, Fuller DD. Intermittent hypoxia and neurorehabilitation. J Appl Physiol (1985). 2015 Dec 15;119(12):1455-65. doi: 10.1152/japplphysiol.00235.2015. Epub 2015 May 21. — View Citation
Hayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27. — View Citation
Satriotomo I, Nichols NL, Dale EA, Emery AT, Dahlberg JM, Mitchell GS. Repetitive acute intermittent hypoxia increases growth/neurotrophic factor expression in non-respiratory motor neurons. Neuroscience. 2016 May 13;322:479-88. doi: 10.1016/j.neuroscience.2016.02.060. Epub 2016 Mar 2. — View Citation
Sutor T, Cavka K, Vose AK, Welch JF, Davenport P, Fuller DD, Mitchell GS, Fox EJ. Single-session effects of acute intermittent hypoxia on breathing function after human spinal cord injury. Exp Neurol. 2021 Aug;342:113735. doi: 10.1016/j.expneurol.2021.113 — View Citation
Tester NJ, Fuller DD, Fromm JS, Spiess MR, Behrman AL, Mateika JH. Long-term facilitation of ventilation in humans with chronic spinal cord injury. Am J Respir Crit Care Med. 2014 Jan 1;189(1):57-65. doi: 10.1164/rccm.201305-0848OC. — View Citation
Trumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Maximal Inspiratory Pressure | An assessment of inspiratory muscle strength. | Change between baseline and 30 minutes post-intermittent hypoxia or sham. | |
Primary | Change in Maximal Expiratory Pressure | An assessment of expiratory muscle strength. | Change between baseline and 30 minutes post-intermittent hypoxia or sham. | |
Primary | Change in Forced Vital Capacity | An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort. | Change between baseline and 30 minutes post-intermittent hypoxia or sham. | |
Primary | Change in Mouth Occlusion Pressure (P0.1) | An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation. | Change between baseline and 30 minutes post-intermittent hypoxia or sham. |
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