Using hypoxia to improve recovery of upper limb function after spinal cord injury
Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair
This study is testing if a special breathing technique combined with movement training can help improve arm function in people who have had a spinal cord injury.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Hines, Illinois) |
| Trial ID | NCT03780829 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of repetitive exposure to acute intermittent hypoxia (rAIH) combined with motor training on improving upper limb function in an adult rat model of chronic contusive spinal cord injury (cSCI). The researchers aim to enhance the neuroplasticity effects of rAIH/training to promote recovery of forelimb function, which is significantly impaired after cSCI. By examining different frequencies and doses of rAIH, as well as the impact of D-cycloserine on synaptic plasticity, the study seeks to develop more effective rehabilitation strategies for individuals with cSCI. The findings may also have implications for other motor disorders that affect upper limb function.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18-85 with chronic cervical spinal cord injuries who have some sensory function and can perform basic grasping tasks.
Not a fit: Patients with complete sensory loss or those with uncontrolled medical problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved rehabilitation techniques for patients with spinal cord injuries, enhancing their quality of life.
How similar studies have performed: While the approach of using hypoxia to promote recovery is being explored, this specific combination of rAIH and motor training in the context of cSCI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and females Veterans between 18-85 years * Chronic cSCI (1 yr of injury) * Cervical injury at C8 or above * Sensory function: impaired (score of 1) but not absent (score of 0) or intact (score of 2) innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores * Motor function: Able to grasp small objects with one hand and able to perform a visible precision grasp between the index finger and thumb * Motor scores ISNCSCI: 1 to 4 but not 5 on finger flexors and finger abductors on the hand tested. * These criteria were selected to ensure that hand impairment will not interfere with the ability to perform training and proposed tests Inclusion criteria for controls: * Male and females (18-80 years) * Right handed * Able to complete precision and power grips Exclusion Criteria: * Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease * Any debilitating disease prior to the SCI that caused exercise intolerance * Premorbid, ongoing major depression or psychosis, altered cognitive status * History of head injury or stroke * Metal plate in skull * History of seizures * Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs * chlorpromazine * clozapine * or tricyclic antidepressants * Pregnant females * Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease as spinal stenosis, spina bifida or herniated cervical disk * AIH Exclusion Criteria (in addition to the above listed exclusion criteria): * resting heart rate \> 120 bpm * resting systolic blood pressure \>180 mmHg * resting diastolic blood pressure \>100 mmHg * self-reported history of unstable angina or myocardial infarction within the previous month * resting SpO2 \> or equal to 95% * cardiopulmonary complications such as COPD Exclusion criteria for healthy controls: * Same as for SCI individuals
Where this trial is running
Hines, Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Martin Oudega, PhD — Edward Hines Jr. VA Hospital, Hines, IL
- Study coordinator: Martin Oudega, PhD
- Email: moudega@sralab.org
- Phone: (305) 575-7000
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.