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Device

Electrical Stimulation + Vitamin D for Spinal Cord Injury

Phase 2 & 3

Waitlist Available

Led By Dora E Ifon, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have Knee extensors that must respond to standard surface electrical stimulation procedures

Be a Veteran (male or female)

Must not have

Other medical conditions including cardiovascular disease, uncontrolled type II DM, active deep vein thrombosis (DVT), uncontrolled autonomic dysreflexia, use of insulin for DM management, pressures injuries of stage 3 or higher, or active urinary tract infection

Unable to tolerate increasing either electrical stimulation current or weights to the lower legs for any reason

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0. 4.5 months and 9 months

Awards & highlights

Summary

This trial will test whether electrical stimulation and vitamin D can help improve bone quality for veterans with spinal cord injuries, which often leads to osteoporosis and increased risk of fractures.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation, muscle fatigue after resistance training sessions, possible skin irritation where electrodes are placed for NMES therapy, and typical risks associated with taking supplements such as mild gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My knee muscles respond to electrical stimulation.

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I am a veteran.

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I am between 18 and 65 years old.

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I use a wheelchair as my main way to get around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My high blood pressure is not being treated or controlled.

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I am older than 65.

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I use a prosthetic for my lower limb.

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I don't have anyone to assist me with using the rowing machine.

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I have severe muscle stiffness that affects my daily activities.

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My spinal injury is severe but I have some motor function.

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I have no healing issues with bones in my arms or legs.

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I have severe osteoporosis.

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I have a neurological injury that is not a spinal cord injury.

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I have severe scoliosis or joint problems that limit my movement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0. 4.5 months and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0. 4.5 months and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0. 4.5 months and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Trabecular microarchitecture

Changes in trabecular microarchitecture

Secondary outcome measures

Changes in Bone biomarkers

Changes in Bone mineral density

Changes in Muscle area

+1 more

Side effects data

From 2015 Phase 3 trial • 486 Patients • NCT02014467

Arthralgia

Blood cholesterol increased

Any event

Femoral neck fracture

Bone density decreased

100%

80%

60%

40%

20%

Study treatment Arm

Denosumab 60mg

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Group I: Passive movement plus vitamin DExperimental Treatment2 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 DExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D

2013

Completed Phase 4

~3470

NMES

2018

Completed Phase 4

~890