Recruiting

Oxygen, TCS, Walking

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT06521723

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Daily acute intermittent hypoxia

Walking + tSTIM

Study Details

Brief 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

Study ID

NCT06521723

Start date

Jun 6, 2025

Status verified date

Mar, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 to 80 years of age
  • medically stable with medical clearance from study physician to participate
  • SCI at or below C1 and at or above L2 with at least some sensory or motor function preserved below the neurologic level
  • non-progressive etiology of spinal injury
  • American Spinal Injury Association (ASIA) scores of C-D at initial screen
  • ambulatory (able to complete the 10-meter walk test without support from another person)
  • chronic injury (define as > 12 months post-injury) to avoid potential for spontaneous neurological plasticity and recovery

Exclusion Criteria:

  • severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis, active heterotopic ossification in the lower extremities, severe systemic inflammation
  • < 24 on Mini-Mental Exam
  • severe recurrent autonomic dysreflexia
  • history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure > 150 mmHg)
  • pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded)
  • botulinum toxin injections in lower extremity muscles within the prior three months
  • history of tendon or nerve transfer surgery in the lower extremity
  • untreated severe sleep-disordered breathing characterized by uncontrolled hypoxia and sleep fractionation that may impact the outcome of this study.
  • active implanted devices (e.g., intrathecal baclofen pump)
  • receiving concurrent electrical stimulation
  • motor threshold evoked by transcutaneous spinal stimulation >200 mA

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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).

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Noah Piazza

(617) 952-6953npiazza2@mgb.org

Randy Trumbower, PT, PhD

rtrumbower@mgb.org

Locations

Brooks Rehabilitation Hospital

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Holly Carstens, COTA/L, CBIS

904-696-4656Holly.Carstens@BrooksRehab.org

Principal Investigator:

Emily Fox, PT, PhD

Spaulding Rehabilitation Hospital

Recruiting

Cambridge, Massachusetts, United States, 02128

Contacts

Noah Piazza, BS

(617) 952-6953npiazza2@mgb.org

Principal Investigator:

Randy Trumbower, PT, PhD

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • Walk
  • Rehabilitation
  • Strength
  • Movement
  • Low oxygen
  • Electrical stimulation
  • Gait training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2026-03-20.