Low Oxygen Therapy to Enhance Walking Recovery After SCI.

Drug

Standing/walking/mobility

Online since 15 March 2025, updated 66 days ago

About this trial

This trial is enrolling 60 individuals with chronic spinal cord injury to test the effect of acute intermittent hypoxia (AIH) combined with skin-surface (transcutaneous) spinal stimulation (tSCS) and walking training on walking function. AIH is an intervention that may affect nerve plasticity by alternating breathing air with low oxygen content for brief periods with breathing room air with normal oxygen content. tSCS is a technique for stimulating the spinal via surface electrodes to modify spinal cord function. If included, participants will undergo 16 sessions over 4 weeks of either daily AIH followed by 45 minutes of gait training paired with tSCS, or sham AIH followed by the same gait training and SCS protocols. Final testing of walking function will be performed after 14 weeks.

Included participants

Gender

All

Age

18 - 80 years

Injury level

C1 - L2

Severity (AIS)?

AIS-C

AIS-D

Time since injury

≥ 1 year

Healthy volunteers

C1-L2

Additionally, participants must

be able to complete the 10-meter walk test without support from another person

NOT have an active implanted devices (e.g., intrathecal baclofen pump)

What’s involved

Type

Drug

Details

- Participants will undergo 16 sessions over 4 weeks of either daily acute intermittent hypoxia (AIH) followed by 45 minutes of gait training paired with transcutaneous spinal cord stimulation (SCS), or sham AIH followed by the same gait training and SCS protocol. - AIH is an intervention to test the effect on plasticity resulting from repeatedly breathing air with low oxygen content for brief periods, alternating with breathing room air with normal oxygen content. - SCS is a technique for stimulating the spinal cord via surface stimulation to modify spinal cord function. - Final testing of walking function will be performed after 14 weeks.

Potential benefits

Main benefits

Standing/walking/mobility

Additional benefits

Bladder health/function

Bowel health

General health

Pain

Spasticity

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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