BioFLO for Respiratory Recovery in SCI

Description

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.

Conditions

Spinal Cord Injuries

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Study Overview

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Study Details

Study overview

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.

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

BioFLO for Respiratory Recovery in SCI

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Brooks Rehabilitation, Jacksonville, Florida, United States, 32216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults 18-70 years of age
  • * Chronic SCI for \> 1 year, at or below C-3 to T-12
  • * Incomplete SCI based on residual sensory or 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
  • * Medically stable with physician clearance
  • * SCI due to non-progressive etiology
  • * 20% impairment in maximal inspiratory or expiratory pressure generation, relative to normative values
  • * Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury
  • * Severe illness or infection, including non-healing decubitus ulcers, untreated bladder or urinary tract infections, cardiovascular disease, lung disease, active heterotopic ossification, or uncontrolled hypertension
  • * Severe neuropathic pain
  • * Known pregnancy
  • * Severe recurrent autonomic dysreflexia

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Emily Fox, DPT, MHS, PhD, PRINCIPAL_INVESTIGATOR, University of Florida & Brooks Rehabilitation

Study Record Dates

2027-09