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Air Mixture + Electrical Stimulation for Spinal Cord Injury (AIHH+tSCS Trial)

N/A

Recruiting

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

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

Must have

Non-progressive or central cord spinal cord injury from C2-T1 inclusive

American Spinal Injury Association (ASIA) Impairment Scale or AIS classification B, C, or D

Must not have

Has uncontrolled cardiopulmonary disease or cardiac symptoms based on medical records and/or abnormal response to intervention

Has diffuse lower motor neuron injury rendering majority of muscles not excitable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Summary

This trial will see if a combination of special breathing, electric stimulation, and exercise can help improve breathing and arm muscle strength in people with spinal cord injury. #SCI #SpinalCordInjury #ClinicalTrial

Who is the study for?

Adults aged 18-65 with non-progressive spinal cord injuries from C2-T1, classified as AIS B, C, or D. They should have impaired breathing strength and be able to engage in therapy programs. Must be at least a year post-injury, capable of consent, have caregiver support, and willing to be recorded.

What is being tested?

The trial tests if a mix of low oxygen and high carbon dioxide air (AIHH), along with electrical stimulation and exercise training can improve breathing and hand function in those paralyzed due to spinal injury. It involves health questions, AIHH exposure, stimulation sessions, strength testing, blood draw and saliva sample.

What are the potential side effects?

Potential side effects may include discomfort from the electrical stimulation or reactions like dizziness or shortness of breath from the therapeutic air mixture (AIHH). Blood draws might cause bruising or infection at the site.

Eligibility Criteria

Inclusion Criteria

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

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My spinal cord injury is between my neck and upper back and is not getting worse.

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My spinal injury is classified as moderate to severe but not complete.

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It has been at least a year since my spinal cord injury.

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I am between 18 and 65 years old.

Exclusion Criteria

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

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I have heart or lung conditions that are not well-managed.

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Most of my muscles do not respond due to nerve damage.

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I have skin issues that prevent me from using electrodes or doing physical activities.

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I have severe injuries that stop me from taking part in rehabilitation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

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

Treatment Details

Study Objectives

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

Primary study objectives

Change in Airway occlusion pressure (P0.1) in minutes of intervention

Change in Forced vital capacity in minutes of intervention

Change in Maximum respiratory voluntary force production in minutes of intervention

+3 more

Secondary study objectives

Change in Cardiovascular Response in minutes of intervention

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: SHAM AIHH + tSCS-paired Strength TrainingExperimental Treatment2 Interventions

Participants will receive exposure to SHAM AIHH followed by transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.

Group II: AIHH + SHAM tSCS-paired Strength TrainingExperimental Treatment2 Interventions

Participants will receive exposure to AIHH followed by SHAM transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.

Group III: AIHH + tSCS-paired Strength TrainingActive Control2 Interventions

Participants will receive exposure to AIHH followed by transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.

Group IV: SHAM AIHH + SHAM tSCS-paired Strength TrainingPlacebo Group2 Interventions

Participants will receive exposure to SHAM AIHH followed by SHAM transcutaneous spinal cord stimulation-paired respiratory and upper extremity strength training.

0 / 8Eligibility criteria met