← Back to Search

Behavioural Intervention

Breathing Therapy for Spinal Cord Injury

N/A

Recruiting

Led By Emily Fox, DPT, MHS, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Incomplete SCI based on residual sensory or motor function below the level of the injury, or injury classification of B, C, D at initial screening, according to the American Spinal Injury Association Impairment Classification, and the International Standards for the Neurological Classification of SCI

Adults 18-70 years of age

Must not have

Severe illness or infection, including non-healing decubitus ulcers, untreated bladder or urinary tract infections, cardiovascular disease, lung disease, active heterotopic ossification, or uncontrolled hypertension

Exclusion for involvement in TMS - History of seizure disorder, uncontrolled migraines, presence of cardiac pacemaker, metal implants in skull, medications that lower seizure threshold

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, and 45-60 minutes after intervention on aih day, aihh day, and sham aih day

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a therapy of breathing low oxygen air to stimulate spinal neuroplasticity, to see if it improves motor function after spinal cord injury. It also tests if genetics play a role.

Who is the study for?

This trial is for adults aged 18-70 with chronic spinal cord injury (SCI) at or below C-3 to T-12, who have had the condition for over a year and show some impairment in breathing strength. It's not open to those with other neurological conditions, severe pain, major illness, certain metal implants, or uncontrolled medical issues like hypertension.

What is being tested?

The study tests two types of breathing treatments: AIH which uses low oxygen air and AIHH that adds slightly more carbon dioxide. Participants will also do task-specific training. The goal is to see if these can improve respiratory function after SCI and if genetics affect the outcome.

What are the potential side effects?

Potential side effects may include discomfort from wearing a mask during treatment sessions and possible dizziness or shortness of breath due to changes in oxygen levels. However, specifics on side effects are not detailed here.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have some feeling or movement below my spinal injury.

Select...

I am between 18 and 70 years old.

Select...

I have had a spinal cord injury for over a year, between my neck and mid-back.

Select...

My spinal cord injury is not getting worse.

Exclusion Criteria

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

Select...

I do not have severe illness or uncontrolled conditions like heart disease, lung disease, or high blood pressure.

Select...

I don't have seizures, uncontrolled migraines, a pacemaker, skull implants, or take seizure-lowering meds.

Select...

I experience severe and repeated episodes of autonomic dysreflexia.

Select...

I have a neurological condition like MS, Parkinson's, stroke, or brain injury.

Select...

I suffer from severe nerve pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, and 45-60 minutes after intervention on aih day, aihh day, and sham aih day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, and 45-60 minutes after intervention on aih day, aihh day, and sham aih day

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and 45-60 minutes after intervention on aih day, aihh day, and sham aih day 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 maximal expiratory pressure

Change in maximal inspiratory pressure

Change in motor evoked potential

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single-session testing daysExperimental Treatment3 Interventions

Participants will complete three separate single-session testing days. Baseline testing will be performed, then on each day, participants will receive AIH, AIHH, and sham AIH in random order. Post-testing will occur after each intervention.

Group II: Respiratory strength training blocksExperimental Treatment3 Interventions

Participants will complete three separate respiratory strength training blocks. In each block, participants will receive 5 days of AIH, 5 days of AIHH, and 5 days of sham AIH in random order, followed by respiratory strength training. Each block will include 5 days of intervention and training, and post-testing 1, 3, and 7 days after intervention and training has concluded.

0 / 9Eligibility criteria met