Breathing-based AIH treatment for arm tightness after incomplete spinal cord injury
Does the Administration of Acute Intermittent Hypoxia in Persons With Chronic Spinal Cord Injury Make Spasticity Worse?
This trial will try brief episodes of low-oxygen breathing (acute intermittent hypoxia) to see if it changes arm muscle tightness in adults with incomplete cervical spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07583498 on ClinicalTrials.gov |
What this trial studies
Adults with chronic incomplete cervical spinal cord injury (ASIA C or D) who have measurable spasticity will receive an acute intermittent hypoxia (AIH) breathing intervention at a single center. Researchers will measure reflex thresholds in the biceps brachii and other spasticity metrics before and after AIH to see whether neuronal excitability and muscle tightness change. The protocol excludes people with significant cardiopulmonary disease, uncontrolled hypertension, recent botulinum toxin to the arm, current baclofen use, pregnancy, or need for mechanical ventilation. The work builds on prior observations that AIH can transiently increase voluntary strength and spinal plasticity, while specifically examining possible changes in spasticity.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with a non-progressive cervical spinal cord injury at least six months old (C1–C8), classified ASIA C or D, who have measurable upper-extremity spasticity and can safely tolerate brief hypoxic exposures.
Not a fit: Patients with complete injuries, inaccessible neuronal receptor function suggested by very high spasticity, or those with excluded conditions (significant cardiopulmonary disease, uncontrolled hypertension, current baclofen use, recent botulinum toxin, pregnancy, tracheostomy/mechanical ventilation, epilepsy, or major cardiac disease) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, AIH could offer a short, noninvasive way to alter spinal excitability and potentially improve muscle control for some people with incomplete SCI.
How similar studies have performed: Prior small studies show AIH can rapidly boost voluntary strength and promote spinal plasticity for several hours, but effects on spasticity are less well-established and may in some cases increase motor neuron excitability.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 * Non-progressive spinal Cord injury at least 6 months prior * Level of injury between C1-C8 * ISNCSCI ASIA classification C or D * Measurable Spasticity Exclusion Criteria: * Pre-existing hypoxic pulmonary disease * Positive Covid-Pneumonia diagnosis within 1 year of visit * Uncontrolled hypertension \>140/90 mmHg * Individuals who are currently pregnant/nursing or planning on becoming pregnant * Individuals with a tracheostomy or who utilize mechanical ventilation * A botulinum toxin injection to upper extremity musculature within the past 3 months * Currently taking Baclofen * Congestive Heart Failure * Cardiac arrhythmias * Uncontrolled diabetes mellitus * Chronic obstructive pulmonary disease * Emphysema * Severe Asthma * Previous myocardial infarction * Carotid/intracerebral artery stenosis * Orthopedic injuries or surgeries that impact the ability to use the upper extremity * History of Epilepsy
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: William Z Rymer, MD, PhD — Shirley Ryan AbilityLab
- Study coordinator: William Z Rymer, MD, PhD
- Email: w-rymer@northwestern.edu
- Phone: 312-238-3919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.