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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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