Combining low oxygen therapy and spinal stimulation to improve walking after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of combining acute intermittent hypoxia (AIH) with transcutaneous spinal cord stimulation (tSTIM) and walking training to enhance recovery of walking function in individuals with chronic spinal cord injuries. Participants will undergo daily sessions of AIH, alongside walking training with either tSTIM or a sham treatment. The approach is based on previous animal studies that suggest AIH can promote neural plasticity and improve spinal cord function. The ultimate goal is to determine if this combination leads to greater improvements in walking ability compared to using AIH or tSTIM alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Shirley Ryan AbilityLab
  Chicago, Illinois, United States Recruiting
• Spaulding Rehabilitation Hospital
  Cambridge, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Randy Trumbower, PT, PhD — Harvard Medical School (HMS and HSDM)
• Study coordinator: Noah Piazza, BS
• Email: npiazza2@mgb.org
• Phone: 617-952-6953

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.