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Behavioural Intervention
Repetitive Acute Intermittent Hypoxia for Spinal Cord Injury
N/A
Recruiting
Led By Monica A Perez, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
SCI at or above L2
ASIA A, B, C, or D, complete or incomplete
Must not have
Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
History of head injury or stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-10 minutes
Summary
This trial is testing if a treatment of acute intermittent hypoxia, or periods of low oxygen, can help improve function in people with chronic spinal cord injury.
Who is the study for?
This trial is for adults aged 18-85 with chronic spinal cord injury at or above L2, who can grip with one hand or move their wrist and ankle slightly. It's not for those with uncontrolled medical issues, recent heart problems, pregnancy, seizure history, certain medication use, previous brain injuries or conditions affecting the spine other than SCI.
What is being tested?
The study tests whether repeated sessions of acute intermittent hypoxia (brief periods of low oxygen) combined with upper and lower limb training can improve limb function in people with long-term spinal cord injuries.
What are the potential side effects?
Potential side effects may include discomfort from low oxygen levels like headache or shortness of breath during the hypoxia exposure. Training might cause muscle soreness. There's also a risk of seizures due to fluctuating oxygen levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal cord injury is at or above the L2 level.
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My spinal cord injury is classified as ASIA A, B, C, or D.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have unmanaged lung, heart, or bone problems.
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I have had a stroke or head injury in the past.
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I have a history of seizures.
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I am taking medication that affects my brain and could make seizures more likely.
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I have a lung or heart condition like COPD.
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I have a spinal condition like stenosis, spina bifida, or a herniated disk.
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I had a condition before my spinal cord injury that made it hard for me to exercise.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-10 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
EMG and force voluntary output
Lower limb functional measurement
MEP/CMEP recruitment curves using TMS
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: rAIH + training by research staffActive Control3 Interventions
Participants will receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by research staff.
Group II: sham rAIH + trainingPlacebo Group3 Interventions
Participants will sham receive repeated exposure to acute Intermittent Hypoxia (rAIH) and training by the research staff.
Find a Location
Who is running the clinical trial?
U.S. Department of EducationFED
86 Previous Clinical Trials
54,672 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
208 Previous Clinical Trials
17,965 Total Patients Enrolled
Monica A Perez, PhDPrincipal InvestigatorShirley Ryan AbilityLab
3 Previous Clinical Trials
303 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have unmanaged lung, heart, or bone problems.You have a history of severe depression or psychosis, or ongoing problems with thinking clearly.Your heart beats more than 120 times per minute when you are resting.My spinal cord injury is at or above the L2 level.I can slightly move my toes upwards and bend my hip.I have had a stroke or head injury in the past.I have a history of seizures.I am taking medication that affects my brain and could make seizures more likely.Your blood pressure when you are resting is higher than 100 mmHg.Your oxygen level is at least 95% when you are resting.I have a lung or heart condition like COPD.I have had a spinal cord injury for 6 months or more.My spinal cord injury is classified as ASIA A, B, C, or D.I can grip things with one hand and move my wrist a little.I have had a heart attack or severe chest pain in the last month.Your blood pressure when you are not active is higher than 180 mm Hg.I am between 18 and 85 years old.You have a metal plate in your skull.I have a spinal condition like stenosis, spina bifida, or a herniated disk.I had a condition before my spinal cord injury that made it hard for me to exercise.
Research Study Groups:
This trial has the following groups:- Group 1: sham rAIH + training
- Group 2: rAIH + training by research staff
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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