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Low Oxygen Therapy to Enhance Walking Recovery After SCI.

NCT06521723 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-20

No results posted yet for this study

Summary

The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury of different age groups.

Conditions

  • Spinal Cord Injuries

Interventions

OTHER

Daily acute intermittent hypoxia

Each participant will be exposed to 16 sessions of daily acute intermittent hypoxia via air generators over the span of four weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02).

DEVICE

Walking + tSTIM

Individuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Brooks Rehabilitation

    collaborator OTHER

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Spaulding Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Randy Trumbower, PT, PhD · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-06
Primary Completion
2027-09-30
Completion
2028-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06521723 on ClinicalTrials.gov