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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve bone health in Veterans with spinal cord injuries. Researchers are testing whether combining electrical muscle stimulation (which uses electrical impulses to contract muscles) with Vitamin D can strengthen bones and reduce fracture risk. Participants will be divided into two groups: one will perform muscle training exercises with electrical stimulation and take Vitamin D, while the other will engage in passive movement exercises with Vitamin D. The trial seeks Veterans who primarily use a wheelchair and have a traumatic spinal cord injury. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anti-coagulation or anti-platelet therapy, including aspirin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that neuromuscular electrical stimulation (NMES) is generally safe, with thousands of sessions recorded without major problems. It has been used effectively in treating spinal cord injuries. Previous studies support combining NMES with vitamin D, showing it is well-tolerated.

For the passive movement plus vitamin D approach, studies suggest that vitamin D is safe and important for health after a spinal cord injury, aiding muscle health and other body functions. Passive movement exercises improve heart and muscle health without causing harm.

Past studies have shown these treatments to be well-tolerated, providing reassurance of their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for spinal cord injury because they combine innovative approaches that differ from traditional methods like surgery or medication. The first treatment arm uses Neuromuscular Electrical Stimulation (NMES) alongside Vitamin D, which aims to enhance muscle strength and nerve function through electrical impulses, while the added Vitamin D may support bone health and immune function. The second treatment arm pairs passive movement exercises with Vitamin D, which could offer a gentler, home-based rehabilitation strategy that still supports overall recovery. These approaches not only introduce new mechanisms—like electrical stimulation and passive movement—but also focus on integrating daily Vitamin D supplementation to potentially boost the effectiveness of physical rehabilitation.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that Neuromuscular Electrical Stimulation (NMES) combined with Vitamin D, which participants in this trial may receive, might improve bone health for individuals with spinal cord injuries. Studies indicate that NMES can slow bone loss in the legs, crucial because spinal cord injuries often weaken bones. Vitamin D strengthens bones and aids recovery by enhancing muscle function.

Another group in this trial will receive passive movement and Vitamin D. This approach involves Vitamin D supplements, which may correct low Vitamin D levels common in individuals with spinal cord injuries and can slow recovery. Passive movement might boost blood flow, potentially supporting bone health. Together, these treatments aim to address bone issues related to spinal cord injuries in different ways. ^{1 4 6 7 8}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05008484

Effects of Electrical Stimulation and Vitamin D ... In the present pilot study, we will evaluate the effect of Neuromuscular Electrical Stimulation Resistance Training in combination with oral Vitamin D ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12122546/

Electrical stimulation paradigms on muscle quality and bone ... The findings suggested that enhancing the components of muscle quality via NMES-RT may attenuate BMD loss in the distal femur following 12 weeks of FES- lower ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/84/NCT05008484/ICF_000.pdf

Effects of Electrical Stimulation and Vitamin D ... This study involves research with spinal cord injured people. The purpose of this research study is to determine the effect of home-based ...

4. researchgate.net researchgate.net/publication/279988908_Cholecalciferol_vitamin_D3_improves_Functional_Recovery_when_Delivered_during_the_Acute_Phase_after_a_Spinal_Cord_Trauma

Cholecalciferol (vitamin D3) improves Functional Recovery ... Vitamin D3 oral solution at a dose of 500 IU/kg/day improved functional recovery such as locomotor activity, H-reflex depression, breathing, and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5791925/

Does Neuromuscular Electrical Stimulation Therapy ... Conclusions: There is some suggestion that NMES increases voluntary strength in partially paralyzed muscle following SCI. However, there is no strong evidence ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3660124/

The Effects of Aging and Electrical Stimulation Exercise on ... Electrical stimulation activities administered appropriately are assumed safe due to thousands of documented safe FES cycling sessions. However, ...

7. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=55

Neuromuscular Electrical Stimulation (NMES) for Spinal ... Neuromuscular Electrical Stimulation (NMES) for Spinal Cord Injury ... 17 FDA Summary of Safety and Effectiveness Data for PMA Application P900038, 1994.

8. nature.com nature.com/articles/sc2011149

Spinal cord injury and physical activity: preservation of the ... The objective of this review was to examine the evidence for the effects of physical rehabilitation strategies on health and fitness.