Intermittent Hypoxia + Upper Limb Training for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Shirley Ryan AbilityLab

No Placebo Group

Trial Summary

What is the purpose of this trial?Currently, there are a variety of approaches utilized in attempts to improve upper extremity function, including: traditional therapy, neuroprostheses, botulinum toxin injections, or surgical interventions. In addition, regenerative and restorative therapies, such as: epidural stimulation, functional electrical stimulation, and stem cell therapies, show promise in animal models, but are not ready for clinical translation. Subsequently, there is a clear need to develop new strategies that can stimulate spinal plasticity and strengthen existing synaptic connections in order to maximize the benefits of training paradigms. This study proposes the examine the effects of Acute Intermittent Hypoxia (AIH) in combination with upper extremity training, over the course of a month, to evaluate changes in upper extremity function, dexterity, and ability to complete activities of daily living. The use of acute intermittent hypoxia (AIH) has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (\<2 min) exposures to reduced oxygen levels (\~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (\~21% inspired oxygen). Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.

Eligibility Criteria

This trial is for individuals with non-progressive spinal cord injuries at levels C1-T1, who have some hand muscle activation or can use a tenodesis grasp. They must be over 6 months post-injury, not severely anemic (hemoglobin ≥10g/dl), and have stable blood pressure. It's not suitable for those with certain medical conditions like uncontrolled hypertension or diabetes, severe respiratory issues, heart problems, pregnant women, or those on mechanical ventilation.

Inclusion Criteria

I can move my hand muscles or use my wrist to grasp.

I do not experience symptoms like dizziness or lightheadedness.

My blood hemoglobin level is at least 10g/dl.

I have had a stable spinal cord injury between the neck and upper back.

My spinal cord injury is not getting worse over time.

Exclusion Criteria

I have a brain injury affecting my thinking or memory.

I do not have severe heart, lung, blood pressure, or diabetes issues.

I am currently pregnant or planning to become pregnant.

I have been diagnosed with obstructive sleep apnea.

I have no recent surgeries or injuries that limit my movement.

Participant Groups

The study tests the effect of Acute Intermittent Hypoxia (AIH) combined with upper limb training to improve arm function in spinal cord injury patients. AIH involves short exposures to low oxygen followed by normal air and has shown promise in enhancing motor function when paired with physical training.

4Treatment groups

Active Control

Group I: Acute Intermittent Hypoxia (AIH) treatmentActive Control1 Intervention

Group II: AIH in combination with upper extremity trainingActive Control1 Intervention

The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask. The mask is designed to couple with a universal mask circuit connecting to the air mixture system. The purpose of the mask will be to minimize room air entrainment. In addition to this upper extremity training will be given using an upper-limb robotic rehabilitation device.

Group III: Sham AIH therapy in combination with upper extremity trainingActive Control1 Intervention

Sham hypoxia followed by upper extremity training will be given using an upper-limb robotic rehabilitation device (Armeo Spring®, Hocoma AG, Switzerland). Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.

Group IV: Sham AIH therapyActive Control1 Intervention

Sham hypoxia