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AIH for Spinal Cord Injury

Phase < 1

Recruiting

Led By Martin Oudega, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Male and females Veterans between 18-85 years

Chronic cSCI (1 yr of injury)

Must not have

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

Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week

Summary

This trial looks at a new way to help people with spinal cord injuries improve their arm and hand function.

Who is the study for?

This trial is for adults aged 18-85 with chronic cervical spinal cord injury (cSCI) at least a year old, who can perform certain hand grips and have some sensory function in specific areas. It's not for those with severe heart conditions, uncontrolled medical issues, major depression or psychosis, history of head injury or stroke, metal plates in the skull, seizure history, CNS-affecting drugs use, pregnancy or ongoing spinal complications.

What is being tested?

The study tests whether combining acute intermittent hypoxia (rAIH) with motor training enhances upper limb function recovery after cSCI. Using an adult rat model first to inform human trials later on. Participants will undergo rAIH and exercise training versus sham treatments to compare effects on motor skills.

What are the potential side effects?

Potential side effects may include discomfort from hypoxia exposure such as shortness of breath or lightheadedness during sessions; exercise-related muscle soreness; and risks associated with D-cycloserine if used in humans could involve allergic reactions or neurological changes.

Eligibility Criteria

Inclusion Criteria

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

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I am a veteran aged between 18 and 85.

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I have had a spinal cord injury for over a year.

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I can firmly grasp and hold objects.

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I can pick up small objects and pinch them between my thumb and index finger.

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My spinal injury is at the neck level or higher.

Exclusion Criteria

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

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I am taking medication that affects my brain and could make seizures more likely.

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I have had a head injury or stroke in the past.

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I do not have unmanaged lung, heart, or bone problems.

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I have a history of seizures.

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I had a condition before my spinal cord injury that made it hard for me to exercise.

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I have a spinal condition like stenosis, spina bifida, or a herniated disk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1st week, 2nd week, 4th week, 8th week, and 12th week for reporting.