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Electrical Stimulation + Vitamin D for Spinal Cord Injury
Phase 2 & 3
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0. 4.5 months and 9 months
Awards & highlights
Study 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 belowSelect...
My knee muscles respond to electrical stimulation.
Select...
I am a veteran.
Select...
I am between 18 and 65 years old.
Select...
I use a wheelchair as my main way to get around.
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
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
Secondary outcome measures
Changes in Bone biomarkers
Changes in Bone mineral density
Changes in Muscle area
+1 moreSide effects data
From 2015 Phase 3 trial • 486 Patients • NCT020144677%
Arthralgia
5%
Blood cholesterol increased
1%
Any event
1%
Femoral neck fracture
1%
Bone density decreased
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,583 Total Patients Enrolled
NYU Langone HealthOTHER
1,367 Previous Clinical Trials
839,741 Total Patients Enrolled
Virginia Commonwealth UniversityOTHER
697 Previous Clinical Trials
22,884,976 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe heart disease, uncontrolled diabetes, active blood clots, severe pressure injuries, or a current urinary infection.My knee muscles respond to electrical stimulation.I am a veteran.I cannot handle more electrical stimulation or weight on my legs.I have someone who can help me with my treatment at home.I am between 18 and 65 years old.My high blood pressure is not being treated or controlled.I am older than 65.You have bullets in your spine or metal pieces in your body that could cause problems during an MRI.I use a prosthetic for my lower limb.I don't have anyone to assist me with using the rowing machine.Your heart's electrical activity is normal.I can commit to a 9-month trial involving specific exercises and Vitamin D.I have severe muscle stiffness that affects my daily activities.I am on blood thinners.My spinal injury is severe but I have some motor function.I have no healing issues with bones in my arms or legs.You have a pacemaker, defibrillator, or other metal implants in your body.I have severe osteoporosis.You have severe high calcium levels, advanced kidney disease, are a post-menopausal woman who relies on estrogen, or a man undergoing certain hormone treatments.Your bone density test results show very low bone strength in certain areas of your body.You have a spinal cord injury from a trauma within the past year, and it has caused specific nerve damage in your spine.I have a neurological injury that is not a spinal cord injury.You have a spinal cord injury from a serious accident within the past year, and it affects the nerves in your lower neck or upper back.I use a wheelchair as my main way to get around.I have severe scoliosis or joint problems that limit my movement.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: NMES Plus Vitamin D
- Group 2: Passive movement plus vitamin D
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT05008484 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people can join this trial at its maximum enrollment?
"That is correct, the trial detailed on clinicaltrials.gov is currently looking for participants. 20 patients are needed in total, with recruitment happening at a single site. This particular trial was posted on October 1st, 2021 and last updated on August 26th, 2022."
Answered by AI
Are there previous examples of using NMES as a treatment method?
"Valdemoro, Madrid is the hub for research on NMES with 36 ongoing studies. Out of these investigations, 11 are in Phase 3. However, clinical trials for this treatment are not limited to Valdemoro and can be found in 91 other locations."
Answered by AI
Are we currently looking for participants in this clinical trial?
"The correct, per the clinicaltrials.gov listing, this trial is open for recruitment and currently looking for 20 patients at 1 site. The listing was created on 10/1/2021 and last updated on 8/26/2022."
Answered by AI
To whom does this study's inclusion criteria apply?
"This medical trial is looking for 20 individuals that meet the following requirements: Between 18-65 years of age, Must use a wheelchair as their primary mode of mobility, Obtain written clearance from their doctor to ensure safety, agree to 9 months of the study which includes 4.5 months of resistance training and 4.5 months of closed-kinematic chain using simple rowing + Vitamin d supplementation (Experimental) or 9 months of passive movement +Vitamin D Supplementation (control), Have a caregiver available and willing to apply intervention protocol throughout study duration, have a history of 1 year traumatic SCI with NLI"
Answered by AI
Can adults participate in this particular research project?
"According to the information posted on this website, the age range for patients that qualify for this particular trial are those between 18-65. There appear to be 152 clinical trials for people younger than 18 and 787 for seniors."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
Hunter Holmes McGuire VA Medical Center, Richmond, VA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
I am paralyzed; how will I use a rowing machine?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I haven't tried any drugs to help strengthen my bones in any way and I know I am probably at risk for fractures.
PatientReceived 2+ prior treatments
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