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Can zaps and vitamins save bones after spinal injury?

NCT ID NCT05008484

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether combining neuromuscular electrical stimulation with daily vitamin D could improve bone health in veterans with chronic spinal cord injury. Six participants underwent 9 months of treatment, with bone changes measured by MRI and DXA scans. The goal was to see if this approach could reverse the bone loss that often leads to fractures in this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
neuromuscular electrical stimulation and vitamin D supplementation
What this could lead to
If it works, this could point toward a way to reduce bone loss and fracture risk in people with spinal cord injury.
What could go wrong
This was a very small pilot study with only 6 participants, so results may not apply widely. The combination therapy may not reverse bone loss significantly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

6 people

The number who actually took part.

Started

Oct 2021

Finished

Jun 2024

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: To be included, participants will have to: * Be 18-65 years of age * Have history of traumatic SCI ( 1-year) with NLI of C8-T10 and AIS A or B (confirmed by AIS examination performed by PI or a qualified Provider * Have a caregiver who is available and willing to be trained to apply intervention protocol in the home (placing weights and positioning the Veteran) throughout study duration * Be a wheelchair user for primary mode of mobility * Have Knee extensors that must respond to standard surface electrical stimulation procedures (stimulation frequency procedures, 30 Hz; pulse duration:1 ms and amplitude of the current of less than200 mA) * Be able to receive written clearance from their medical Providers to ensure safety of participants * Be a Veteran (male or female), however, the Department of Veteran Affairs has limited number of female Veterans, especially those with motor complete injury at level C8-T10 (currently, there are only 3 female Veterans with the target NLI in our SCI registry). Hence, inclusion of women Veterans may be challenging due to this disparity in the SCI population. If we fail to recruit 20 Veterans, we may seek an IRB approval to recruit non-Veterans to meet our target sample size * Have normal ECG * Commit to undergo 9 months of trial; 4.5 months of open-kinematic chain resistance training followed by 4.5 months of closed-kinematic chain using simple rowing approach + Vit. D supplementation (Experimental group) or 9 months of passive movement +Vit D supplementation (control group) Exclusion Criteria: Potential participants will be excluded if they exhibit any of the following: * Neurological injury other than SCI * Older than 65 years of age as they may likely have considerable amount of bone loss at that age * Have severe osteoporosis because loading porous/fragile bone by electrical stimulation may result in bone fracture * Those classified as AIS C \& D, as they may already be engaging in weight bearing activities that may confound the results of this trial * Unhealed or unstable fractures in either lower or upper extremities * Severe scoliosis, deformities in the hip, knee, or ankles OR impaired range-of-motion, as these could be a barrier to safe positioning on the rowing machine, and on MRI or DXA tables * No caregiver or family member/significant other, willing to help with placing weights and positioning participants' lower extremities on the rowing machine * Untreated or uncontrolled hypertension (systolic blood pressure (BP) \> 140 mmHg; diastolic BP \> 90 mmHg), and/or sudden hypotension upon transferring from bed to wheelchair, characterized by a drop in BP by 20 mmHg (especially in persons with tetraplegia) or heart rate \> 100 beats per minute * Anti-coagulation or anti-platelet therapy (including aspirin) * Implanted pacemakers, implanted defibrillator devices or any metallic implants including knee or hip implants * Presence of bullets in vertebral column or shrapnel anywhere in the body that may interfere with MRI procedure * 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 * Severe hypercalcemia (serum calcium \> 16mg/dl), stage III-V kidney disease, post-menopausal or estrogen dependent female, and men undergoing anti-androgen therapy or are post orchiectomy * DXA total body T-score less than -2.5. Total hip BMD T-scores \< -3.5 and knee BMD scores of less than 0.6 g/cm2 * Untreatable severe spasticity bearing on potential participants' activities of daily living, such as transfers from bed to wheelchair or maintaining position in wheelchair * Any psychiatric illness confounding judgment or cognitive impairment in participant or caregiver who is expected to help participant in the trial * Those with prosthetic lower limbs * Any condition that, in the judgment of the PI or other medical Providers, preclude safe participation in the study and/or has the potential to expose/increase participant's risk of infection * Unable to tolerate increasing either electrical stimulation current or weights to the lower legs for any reason

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249-0001, United States

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Other studies related to the condition(s) this trial covers.