NCT06521723 Low Oxygen Therapy to Enhance Walking Recovery After SCI.
| NCT ID | NCT06521723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spaulding Rehabilitation Hospital |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-06-06 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Randy Trumbower, PT, PhD
PRINCIPAL INVESTIGATOR
Harvard Medical School (HMS and HSDM)
Frequently Asked Questions
Who can join the NCT06521723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06521723 currently recruiting?
Yes, NCT06521723 is actively recruiting participants. Contact the research team at npiazza2@mgb.org for enrollment information.
Where is the NCT06521723 trial being conducted?
This trial is being conducted at Jacksonville, United States, Cambridge, United States.
Who is sponsoring the NCT06521723 clinical trial?
NCT06521723 is sponsored by Spaulding Rehabilitation Hospital. The principal investigator is Randy Trumbower, PT, PhD at Harvard Medical School (HMS and HSDM). The trial plans to enroll 60 participants.