Electrical Stimulation + Vitamin D for Spinal Cord Injury
Trial Summary
What is the purpose of this trial?
Neurogenic osteoporosis is a common complication of spinal cord injury (SCI) that is associated with low impact bone fractures. It is concerning that more than 46,000 Veterans affected with SCI and are at risk of osteoporosis and possible low impact fractures. About fifty percent of all individuals with SCI will develop low impact fracture in their life time. The management of osteoporosis-related fractures can impose substantial economic burden on the health care system, the individual and the families. Previous studies did not succeed in reversing the process of bone loss after SCI. In the present pilot study, we will evaluate the effect of Neuromuscular Electrical Stimulation Resistance Training in combination with oral Vitamin D supplementation, on bone quality in Veterans with chronic SCI, using a randomized experimental design.
Research Team
Dora E Ifon, PhD
Principal Investigator
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Eligibility Criteria
This trial is for Veterans aged 18-65 with a history of traumatic spinal cord injury (SCI) at least one year prior, specifically with injuries between C8-T10 and classified as AIS A or B. Participants must be wheelchair users, have responsive knee extensors to electrical stimulation, a caregiver to assist, and clearance from their medical provider. Excluded are those over 65, with severe osteoporosis or other major health issues like uncontrolled diabetes or cardiovascular disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo 4.5 months of open kinematic chain resistance training followed by 4.5 months of closed kinematic chain using a simple rowing approach, with daily 2000IU oral vitamin D supplementation
Follow-up
Participants are monitored for changes in trabecular microarchitecture, bone biomarkers, muscle area, bone mineral density, and quality of life
Treatment Details
Interventions
- NMES
- Passive movement
- Vitamin D
NMES is already approved in United States, European Union for the following indications:
- Muscle wasting and weakness after subarachnoid hemorrhage (SAH)
- Rehabilitation post-SAH
- Muscle weakness and wasting in critically ill patients
- Rehabilitation post-SAH
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
NYU Langone Health
Collaborator
Virginia Commonwealth University
Collaborator