Recruiting

Combination Therapy

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT05563103

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Daily acute intermittent hypoxia

Room air (SHAM)

Walking + tSTIM

Walking + Sham transcutaneous spinal stimulation (tSHAM)

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.

Conditions

Spinal Cord Injuries

Study ID

NCT05563103

Start date

Jan 17, 2023

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 to 70 years of age
  • medically stable with medical clearance from study physician to participate
  • SCI at or below C2 (phrenic sparing) 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.

sham comparator: AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)

Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with sham transcutaneous spinal cord stimulation.

Interventions

Daily acute intermittent hypoxia

Each participant will be exposed to 8 sessions of daily acute intermittent hypoxia via air generators over the span of two 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).

Room air (SHAM)

Each participant will be exposed to 8 sessions of daily room air via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes of 1.5 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.

Walking + Sham transcutaneous spinal stimulation (tSHAM)

Individuals will participate in 45 minutes of gait training while having SHAM transcutaneous spinal cord stimulation. The stimulation will briefly increase to 80% involuntary motor threshold and then brought down to 0 within 30 seconds.

Primary outcome measure

  • Change in walking recovery, assessed by 10 meter walk test (10MWT) [ Time Frame: Through study completion, an average of 12 weeks ]
  • Rate of change in walking recovery, assessed by 10 meter walk test (10MWT) [ Time Frame: Through study completion, an average of 12 weeks ]

Central Contacts and Locations

Central contacts

Noah Piazza, BS

617-952-6953npiazza2@mgb.org

Randy Trumbower, PT, PhD

randy.trumbower@mgh.harvard.edu

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Shreya Aalla, BS

312-238-7323saalla@sralab.org

Sara Prokup, PT, DPT

312-238-1355sprokup@ricres.org

Principal Investigator:

Arun Jayaraman, PT, PhD

Spaulding Rehabilitation Hospital

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Noah C Piazza, BS

6179526822npiazza2@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
  • Spinal cord injury
  • low oxygen
  • electrical stimulation
  • walking training

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