RECRUITING

BioFLO for Respiratory Recovery in SCI

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Conditions

Spinal Cord Injuriesacute intermittent hypoxiaspinal cord injurybreathingmotor function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-21
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06011876

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 18-70 years of age
  2. * Chronic SCI for \> 1 year, at or below C-3 to T-12
  3. * 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
  4. * Medically stable with physician clearance
  5. * SCI due to non-progressive etiology
  6. * 20% impairment in maximal inspiratory or expiratory pressure generation, relative to normative values
  1. * Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury
  2. * 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
  3. * Severe neuropathic pain
  4. * Known pregnancy
  5. * Severe recurrent autonomic dysreflexia

Contacts and Locations

Study Contact

Emily J Fox, PT, MHS, PhD
CONTACT
904-742-2500
ejfox@phhp.ufl.edu
Hannah Snyder, M.S.
CONTACT
904-345-6910
Hannah.snyder@brooksrehab.org

Principal Investigator

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

Study Locations (Sites)

Brooks Rehabilitation
Jacksonville, Florida, 32216
United States

Collaborators and Investigators

Sponsor: University of Florida

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-21
Study Completion Date2027-09

Study Record Updates

Study Start Date2023-12-21
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • acute intermittent hypoxia
  • spinal cord injury
  • breathing
  • motor function

Additional Relevant MeSH Terms

  • Spinal Cord Injuries