Low Oxygen Therapy to Enhance Walking Recovery After SCI.

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT06521723
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Daily acute intermittent hypoxia — OTHER
    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).
  • Walking + tSTIM — DEVICE
    Individuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.

Study Details

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.

Key Dates

Start date
Jun 6, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)
    Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.
  • Sham Comparator: Sham + WALKtSTIM
    Sham acute intermittent hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.

Primary Outcome Measure

Change in walking recovery, assessed by 10 meter walk test (10MWT) [ Time Frame: Through study completion, an average of 14 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brooks Rehabilitation HospitalJacksonvilleFlorida32216
Holly Carstens, COTA/L, CBIS
[email protected]
904-696-4656
Emily Fox, PT, PhD (PRINCIPAL_INVESTIGATOR)
Spaulding Rehabilitation HospitalCambridgeMassachusetts02128
Noah Piazza, BS
[email protected]
(617) 952-6953
Randy Trumbower, PT, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Brooks Rehabilitation Hospital· Jacksonville, FLSpaulding Rehabilitation Hospital· Cambridge, MA

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