RECRUITING

Hypoxia Pathways for Early Recovery After Spinal Cord Injury

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

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 (2 weeks to 6 months post injury), is to preliminarily compare the 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. Our 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, we are also 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.

Official Title

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

Quick Facts

Study Start:2025-11-20
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07002437

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. 1. Adults 18-70 years of age
  2. 2. Sub-acute incomplete SCI 2 weeks 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.
  3. 3. Medically stable with physician clearance
  4. 4. SCI due to non-progressive etiology
  1. 1. Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury
  2. 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. 3. Severe neuropathic pain
  4. 4. Known pregnancy
  5. 5. Severe uncontrolled autonomic dysreflexia
  6. 6. Currently hospitalized in an acute care hospital

Contacts and Locations

Study Contact

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

Principal Investigator

Emily J Fox, PT, 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 J Fox, PT, 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 Date2025-11-20
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-11-20
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Injury
  • Intermittent Hypoxia
  • breathing
  • subacute
  • respiratory
  • acute intermittent hypoxia
  • hypoxia

Additional Relevant MeSH Terms

  • Spinal Cord Injuries (SCI)