Low Oxygen Therapy to Enhance Walking Recovery After SCI.

Launched by SPAULDING REHABILITATION HOSPITAL · Jul 21, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a combination of low oxygen therapy, spinal cord stimulation, and walking training can help improve walking abilities in people with chronic spinal cord injuries. The goal is to see if this approach can enhance recovery for individuals of different ages who have some preserved movement or feeling below their injury.

To be eligible for the study, participants need to be between 18 and 80 years old, be medically stable, and have a spinal cord injury at specific levels that allows for some function below the injury site. They should also be able to walk a short distance without assistance and have had their injury for more than a year. Participants will undergo a series of therapies and evaluations to see how well this treatment helps their walking recovery. It’s important to note that certain health conditions and recent treatments may exclude individuals from joining the trial. This study is not yet recruiting participants, but it aims to provide valuable insights into improving mobility for those affected by spinal cord injuries.

Gender

ALL

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