Enhancing limb function recovery in spinal cord injury patients using intermittent hypoxia
Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
This study is testing if a special breathing technique combined with exercise can help people with chronic spinal cord injuries recover better use of their arms and legs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT03433599 on ClinicalTrials.gov |
What this trial studies
This study aims to improve upper and lower limb function recovery in individuals with chronic spinal cord injuries through repeated exposure to acute intermittent hypoxia (rAIH). It will test the hypothesis that rAIH can enhance corticospinal excitability and motor function, and that combining rAIH with exercise training will further improve these outcomes. The study will measure various excitability parameters to understand the mechanisms behind the induced plasticity. Participants must have a chronic spinal cord injury and meet specific functional criteria.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-85 with chronic spinal cord injuries at or above L2 who can perform certain motor tasks.
Not a fit: Patients with uncontrolled medical problems or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor function recovery in patients with spinal cord injuries.
How similar studies have performed: While the approach of using intermittent hypoxia is promising, its application in spinal cord injury recovery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for SCI: 1. Males and females between 18-85 years 2. Chronic SCI (≥ 6 months post injury) 3. SCI at or above L2 4. ASIA A, B, C, or D, complete or incomplete 5. Possess the following: The ability to produce a visible precision grip force with one hand, and/or the ability to perform some small wrist flexion and extension. The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles. Inclusion criteria for controls: 1. Males and females between 18-85 years 2. Right-handed (Only right-handed individuals will be accepted into this group because of the potential differences in the organization of the brain in right handed and left handed individuals) Exclusion criteria for SCI and for controls: 1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease 2. Any debilitating disease prior to the SCI that caused exercise intolerance 3. Premorbid, ongoing major depression or psychosis, altered cognitive status 4. History of head injury or stroke 5. Metal plate in skull 6. History of seizures 7. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressant 8. Pregnant females 9. Ongoing cord compression or a syrinx in the spinal cord or a spinal cord disease as spinal stenosis, spina bifida or herniated cervical disk. AIH exclusion criteria (in addition to the above listed exclusion criteria) 1. Resting heart rate ≥120 BPM 2. Resting systolic blood pressure \>180 mm Hg 3. Resting diastolic Blood Pressure \>100 mmHg 4. Self-reported history of unstable angina or myocardial infarction within the previous month 5. Resting SpO2 ≥ 95% 6. Cardiopulmonary complications such as COPD
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Monica A Perez, PhD — Shirley Ryan AbilityLab
- Study coordinator: Monica Perez, PhD
- Email: mperez04@sralab.org
- Phone: 312-238-2886
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.