Breathing treatment for recovery after spinal cord injury

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

This study is testing if a new breathing treatment can help people with spinal cord injuries recover their breathing and movement better than a standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of Florida (other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT06011876 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with chronic incomplete or complete spinal cord injuries lasting at least one year.

Not a fit: Patients with progressive spinal cord conditions or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve breathing and motor function in patients with spinal cord injuries.

How similar studies have performed: Previous studies have shown promising results with acute intermittent hypoxia approaches, suggesting potential for success in this novel application.

Eligibility criteria

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 this trial is running

Jacksonville, Florida

• 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

Conditions: Spinal Cord Injuries, acute intermittent hypoxia, spinal cord injury, breathing, motor function