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Behavioural Intervention

Intermittent Hypoxia + Upper Limb Training for Spinal Cord Injury

Phase < 1

Waitlist Available

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be able to demonstrate some hand muscle activation, or use of a tenodesis grasp (wrist extension)

Must be asymptomatic (no dizziness, lightheadedness, etc)

Must not have

Comorbid traumatic brain injury or other neurologic injuries that would impact cognition

Medical conditions, including: congestive heart failure, cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known carotid/intracerebral artery stenosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate the effect 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 in individuals with chronic incomplete spinal cord injuries.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While previous studies suggest that AIH is safe, potential side effects may include dizziness or lightheadedness due to fluctuating oxygen levels during treatment sessions. The impact on individual participants could vary based on their specific health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I do not experience symptoms like dizziness or lightheadedness.

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

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

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My spinal cord injury is not getting worse over time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a brain injury affecting my thinking or memory.

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

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I am currently pregnant or planning to become pregnant.

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I have been diagnosed with obstructive sleep apnea.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

GRASSP

Secondary study objectives

9-hole peg test

grip strength

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 10Eligibility criteria met