Breathing treatment for recovery after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of acute intermittent hypoxia (AIH) and acute intermittent hypercapnic-hypoxia (AIHH) on respiratory function and motor recovery in individuals with spinal cord injuries. Participants will undergo a series of tests and receive one of three interventions: AIH, AIHH, or a sham treatment, followed by assessments to measure changes in breathing and motor function. The study also includes respiratory strength training to enhance the effectiveness of the interventions. The goal is to determine if AIHH provides greater benefits compared to AIH and to explore how genetic variations may influence individual responses to these treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults 18-70 years of age
2. 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.
3. Medically stable with physician clearance
4. SCI due to non-progressive etiology
5. 20% impairment in maximal inspiratory, maximal expiratory pressure generation, or both relative to normative values

Exclusion Criteria:

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

Exclusion for involvement in TMS - History of seizure disorder, uncontrolled migraines, presence of cardiac pacemaker, metal implants in skull, medications that lower seizure threshold.

Where it's running

• Brooks Rehabilitation
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Emily Fox, DPT, MHS, PhD — University of Florida & Brooks Rehabilitation
• Study coordinator: Emily J Fox, PT, MHS, PhD
• Email: ejfox@phhp.ufl.edu
• Phone: 904-742-2500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.