Actively Recruiting
Combination Therapy to Improve SCI Recovery.
Led by Spaulding Rehabilitation Hospital · Updated on 2026-03-20
60
Participants Needed
2
Research Sites
202 weeks
Total Duration
On this page
Sponsors
S
Spaulding Rehabilitation Hospital
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination Therapy to Improve SCI Recovery.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 70 years of age
- Medically stable with clearance from study physician to participate
- Spinal cord injury at or below C2 (phrenic sparing) and at or above L2 with some sensory or motor function preserved below the injury level
- Non-progressive cause of spinal injury
- American Spinal Injury Association (ASIA) scores of C-D at initial screening
- Able to walk 10 meters without support from another person
- Chronic injury defined as more than 12 months post-injury to avoid spontaneous recovery
You will not qualify if you...
- Severe concurrent illness or pain, including unhealed pressure sores, severe neuropathic or chronic pain syndrome, severe infection, hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis, active heterotopic ossification in the legs, or severe systemic inflammation
- Mini-Mental Exam score less than 24
- Severe recurrent autonomic dysreflexia
- History of severe cardiovascular or pulmonary complications including systolic blood pressure over 150 mmHg
- Pregnancy due to unknown effects of treatments on fetus
- Botulinum toxin injections in lower leg muscles within the past three months
- History of tendon or nerve transfer surgery in the lower leg
- Untreated severe sleep-disordered breathing causing uncontrolled low oxygen and sleep disruption
- Active implanted devices such as intrathecal baclofen pump
- Receiving concurrent electrical stimulation treatments
- Motor threshold evoked by spinal stimulation greater than 200 mA
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States, 02138
Actively Recruiting
Research Team
N
Noah Piazza, BS
CONTACT
R
Randy Trumbower, PT, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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