Combination Therapy to Improve SCI Recovery.

Launched by SPAULDING REHABILITATION HOSPITAL · Sep 28, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people with chronic spinal cord injuries improve their walking abilities. The study is looking at a combination of low oxygen therapy, a method called transcutaneous spinal cord stimulation (which uses mild electrical currents to stimulate the spinal cord), and walking training. Researchers hope that by combining these approaches, they can enhance the recovery of walking function in individuals who have experienced spinal cord injuries.

To participate in this trial, you need to be between 18 and 70 years old and have a spinal cord injury that meets specific criteria, such as having some preserved sensation or movement below the injury level. You should also be able to walk a short distance without help. Participants will be carefully monitored by medical professionals throughout the study, and the trial is currently looking for volunteers. If you're interested in learning more or think you might be eligible, it’s a good idea to speak with your doctor.

Gender

ALL

Eligibility criteria

• 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