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Taking people in United StatesNo phase

Combination Therapy to Improve SCI Recovery.

Key facts

Who runs it
Spaulding Rehabilitation Hospital
Where
Cambridge and Chicago, United StatesSee the 2 sites
Trial code
Status
Recruiting
People taking part
60 people, planned
Started
17 Jan 2023
Expected to end
Dec 2026
Type of study
Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Daily acute intermittent hypoxia
  • Room air (SHAM)
  • Walking + tSTIM
  • Walking + Sham transcutaneous spinal stimulation (tSHAM)
Record updated
20 March 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • botulinum toxin injections in lower extremity muscles within the prior three months
  • receiving concurrent electrical stimulation
  • history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure > 150 mmHg)
  • history of tendon or nerve transfer surgery in the lower extremity
  • < 24 on Mini-Mental Exam
  • severe recurrent autonomic dysreflexia
  • pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded)
  • 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)
  • motor threshold evoked by transcutaneous spinal stimulation >200 mA

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in United States

  • Spaulding Rehabilitation HospitalCambridge, United StatesContact: Noah C Piazza, BSTaking people
  • Shirley Ryan AbilityLabChicago, United StatesContact: Shreya Aalla, BSTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)Treatment being tested

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

    Treatment: Daily acute intermittent hypoxia and Walking + tSTIM

  • Sham + WALKtSTIMSham treatment, for comparison

    Sham acute intermittent hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.

    Treatment: Room air (SHAM) and Walking + tSTIM

  • AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)Sham treatment, for comparison

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

    Treatment: Daily acute intermittent hypoxia and Walking + Sham transcutaneous spinal stimulation (tSHAM)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery in Persons With Chronic SCI: The BO2ST Trial
Fit questions
Built from NCT05563103, who can take part
Record updated
20 March 2026