NMES for Wounds

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond, VA
Wounds+2 More
NMES - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of exercise and vitamin D supplementation can improve bone quality in people with spinal cord injury.

See full description

Eligible Conditions

  • Wounds
  • Spinal Cord Injuries (SCI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether NMES will improve 1 primary outcome and 4 secondary outcomes in patients with Wounds. Measurement will happen over the course of 0 and 9 months.

0 and 9 months
Changes in Quality of life (QOL)
Month 9
Changes in Bone biomarkers
Changes in Bone mineral density
Changes in Muscle area
Changes in Trabecular microarchitecture

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

NMES Plus Vitamin D
1 of 2
Passive movement plus vitamin D
1 of 2
Experimental Treatment

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. NMES is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

NMES Plus Vitamin DSubjects 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.
Passive movement plus vitamin DSubjects will undergo 9 months of simple passive movement exercise at home 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
FDA approved
NMES
2018
Completed Phase 4
~810

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0. 4.5 months and 9 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 0. 4.5 months and 9 months for reporting.

Closest Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA - Richmond, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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)

Patient Q&A Section

What are the signs of spinal cord injuries?

"The signs of spinal cord injuries include paralysis of all limbs on one side of the body, loss of bowel and bladder control, and bladder or bowel incontinence. Some other signs may include loss of sensation and urinary incontinence." - Anonymous Online Contributor

Unverified Answer

Can spinal cord injuries be cured?

"Despite advances in the field of SCI care, a small but meaningful number of patients survive long-term disability. Survival is strongly associated with completeness of injury, and is higher in younger patients, and in patients with full mobility and good functioning, with or without the use of assistive devices." - Anonymous Online Contributor

Unverified Answer

What causes spinal cord injuries?

"There is no clear cause for spinal cord injuries. A number of factors in the setting of the injury may result in injury, but the mechanism is not known. It is thought that genetic factors predispose to spinal cord injury, resulting in a defect in the central processing of neural signals, leading to a failure in motor and communication between the brain and the body, and to an inability to move. However, other factors, such as injuries, drug use, and malnutrition, have been found to cause serious injuries and complicate treatment. There is no clear cause for these conditions, although they might occur concurrently, or be caused by an underlying genetic predisposition. It is estimated that 10% of individuals with SCI develop chronic pain." - Anonymous Online Contributor

Unverified Answer

What are common treatments for spinal cord injuries?

"A [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) is not treatable by one treatment, but is treatable with many different therapeutic modalities. A variety of medications are commonly prescribed to patients who have sustained spinal cord injuries, and some medications have been shown to have a significant impact on recovery. However, no treatment has been proven to be a 'wins' all treatment – patients still require multiple treatments to achieve the best possible results. Treatment for a spinal cord injury can be divided into functional and psychosocial categories. Functional treatment is focused on minimizing muscle pain, preventing bed sores and bladder control issues. Functional therapy may also include strengthening the patient's muscles, decreasing stress that is caused by their injuries and helping them regain control of their bladder and bowel habit." - Anonymous Online Contributor

Unverified Answer

How many people get spinal cord injuries a year in the United States?

"Approximately 19,000 people get a SCI in the United States each year. This is an estimate since it is difficult to define what constitutes a spinal cord injury. Even if the number of people in the United States sustaining SCI remained constant and no preventive interventions were implemented, it is estimated that approximately 1,400 would still be injured annually. SCI and the associated costs continue to grow as the patient population continues to expand." - Anonymous Online Contributor

Unverified Answer

What is spinal cord injuries?

"This classification would classify SCIs in a very logical way. This classification can be a first step in the process that will eventually lead to an improvement of clinical management and research. A classification scheme will undoubtedly be the ultimate goal to accomplish in the future." - Anonymous Online Contributor

Unverified Answer

Is nmes typically used in combination with any other treatments?

"A common concern about Nmes is potential neurological toxicity. There was moderate to moderate evidence that there is no additive or synergistic effect with Nmes following other treatments. There was moderate to moderate evidence of no synergistic or additive effect with dexamethasone. This is in keeping with the FDA label statement which states that if used in conjunction with another known treatment or medication, the use of DEX + NME should be considered a precaution. However, the FDA will not allow use of NME in conjunction with NESTIN. There was limited evidence that there is a significant decrease in urinary or renal toxicity when compared with the same amount used in combination of placebo." - Anonymous Online Contributor

Unverified Answer

Does spinal cord injuries run in families?

"Results from a recent paper has found only a small number of SCI cases reported to the ABI of SCI registry, with no significant differences between countries. It appears that SCI families tend to be relatively small and the genetic factors associated with SCI is likely to be complex and rare." - Anonymous Online Contributor

Unverified Answer

How does nmes work?

"Results from a recent clinical trial indicate that NMES reduces upper extremity muscle strength in the majority of cases. To confirm a non-pain a positive outcome result from both an intracortical EMG and a transcranial direct current stimulation (tDCS) of the motor cortex. Prospective studies are needed to determine the long term effects of nmes treatment for the treatment of upper extremity muscle wasting secondary to a spinal cord injury." - Anonymous Online Contributor

Unverified Answer

Has nmes proven to be more effective than a placebo?

"Results from a recent paper presented herein are the first to demonstrate that NMes is significantly more effective at reducing pain than a placebo in the acute phase of stroke rehabilitation. A larger study in the subacute and chronic phases of stroke rehabilitation is required." - Anonymous Online Contributor

Unverified Answer

Does nmes improve quality of life for those with spinal cord injuries?

"Recent findings, patients with spinal cord injuries (SCI) reported a marked improvement in their quality of life after their injury (QOLI-SCI), and a marked improvement was seen in patients with nmes after their injury. Recent findings can be further used to develop more comprehensive guidelines that can be used by clinicians who manage SCI patients with nmes." - Anonymous Online Contributor

Unverified Answer

Is nmes safe for people?

"Nmes is a risk tool that carries a serious risk and only should be recommended in those with a history of falls or significant mobility difficulties. Findings from a recent study show that fallers are at particular hazard and this should be taken into account in the decision making on nmes use." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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