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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I can continue my antispasticity medications while in the study.
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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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I will see my doctor for anemia treatment if tests show low blood levels.
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It has been over 6 months since my injury.
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My spinal cord injury is not getting worse over time.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GRASSP
Secondary outcome measures
9-hole peg test
grip strength

Trial Design

4Treatment groups
Active Control
Group I: Acute Intermittent Hypoxia (AIH) treatmentActive 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.
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

Find a Location

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,827 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria for participation in this research?

"This clinical trial is enrolling 92 people with a non-progressive spinal cord injury located between C1 and T1. The candidates must be adults from 18 to 75, have been post-injury for at least six months and not suffer any dizziness or lightheadedness. Additionally, they should demonstrate hand muscle activity, even if it's just a tenodesis grasp (wrist extension). Lastly, participants do not need to cease taking antispasticity medications in order to join the study."

Answered by AI

Is recruitment for this research project still in session?

"Per clinicaltrials.gov, this particular medical trial is in need of participants and has been since November 16th 2018. The information was last revised on July 25th 2022."

Answered by AI

How many participants are engaged in the trial's proceedings?

"Affirmative. According to information from clinicaltrials.gov, this medical experiment is currently recruiting patients and was initially posted on November 16th 2018. The current iteration of the study requires 92 participants at a single site for completion."

Answered by AI

Does this clinical trial accept geriatric patients?

"Patients wishing to join this trial must be between the ages of 18 and 75. There are 175 trials for those under 18 years old, while 826 studies comprise medical research on those surpassing 65."

Answered by AI
~9 spots leftby Mar 2025