Electrical Stimulation + Vitamin D for Spinal Cord Injury

Overseen By Ashraf Gorgey, PhD PT

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: VA Office of Research and Development

Must be taking: Vitamin D

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Neurological injury, Severe osteoporosis, Hypertension, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

7 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Dora E Ifon, PhD

Principal Investigator

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Are You a Good Fit for This Trial?

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

My knee muscles respond to electrical stimulation.

I am a veteran.

I have someone who can help me with my treatment at home.

Exclusion Criteria

Any psychiatric illness confounding judgment or cognitive impairment in participant or caregiver who is expected to help participant in the trial

I do not have severe heart disease, uncontrolled diabetes, active blood clots, severe pressure injuries, or a current urinary infection.

I cannot handle more electrical stimulation or weight on my legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

9 months

Follow-up

Participants are monitored for changes in trabecular microarchitecture, bone biomarkers, muscle area, bone mineral density, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NMES
• Passive movement
• Vitamin D

Trial Overview The study tests the effects of Neuromuscular Electrical Stimulation Resistance Training combined with Vitamin D supplementation on bone health in SCI patients. It's randomized: some will do resistance training plus Vitamin D for 9 months; others get passive movement plus Vitamin D.

How Is the Trial Designed?

Group I: Passive movement plus vitamin D Experimental Treatment 2 Interventions

Subjects will undergo 9 months of simple passive movement exercise at home and 2000IU oral vitamin D supplementation daily for 9 months.

Group II: NMES Plus Vitamin D Experimental Treatment 2 Interventions

Subjects will undergo 4.5 months of open kinematic chain resistance training followed by 4.5 months of closed kinematic chain using simple rowing approach and 2000IU oral vitamin D supplementation daily for 9 months.

NMES is already approved in United States, European Union for the following indications:

Approved in United States as Neuromuscular Electrical Stimulation for:

• Muscle wasting and weakness after subarachnoid hemorrhage (SAH)
• Rehabilitation post-SAH

Approved in European Union as Neuromuscular Electrical Stimulation for:

• Muscle weakness and wasting in critically ill patients
• Rehabilitation post-SAH

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+