Combination Therapy to Improve SCI Recovery.
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSpaulding Rehabilitation Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Daily acute intermittent hypoxia
- Room air (SHAM)
- Walking + tSTIM
- Walking + Sham transcutaneous spinal stimulation (tSHAM)
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Spaulding Rehabilitation Hospital
Lead sponsor
United States Department of Defense
Collaborator
Shirley Ryan AbilityLab
Collaborator
Source ClinicalTrials.gov