Influence of Wearable Intensive Nerve Stimulation on Spasticity & Function

Status Completed

Clinical Trial Summary

Spasticity is muscle spasms, bouncing (clonus) or stiffness that can negatively impact the quality of life of people with spinal cord injury (SCI). In people with spinal cord injury, spasticity can limit muscle control of the arms and hands and cause pain, discomfort, and frustration. Transcutaneous electrical stimulation has been shown to reduce spasticity after SCI. However, this type of stimulation's effects during prolonged, at-home use has not been well studied. Additionally, traditional stimulation techniques are often only available in the clinic. Therefore, this study aims to identify if wearable intensive nerve stimulation decreases spasticity in the legs of people with SCI, and if this intervention is usable and desirable to individuals with SCI.

Clinical Trial Description

Involuntary muscle activation, also referred to as spasticity is a common characteristic of spinal cord injuries. It can present as stiffness, clonus, and spasms that can impact a person's ability to perform daily tasks. Over half of individuals with spinal cord injuries that have spasticity report medication alone does not control the spasticity. Because of this clinical research is investigation different ways to manage spasticity. Stretching and vibration have demonstrated the ability to reduce spasticity but only for short periods of time requiring repeated use of the intervention. Additionally, vibration devices are not very practical to implement at home due to their high cost. Due to these factors, a solution that could be used multiple times a day and remains cost effective is needed. Transcutaneous electrical stimulation (TENS) has also demonstrated effectiveness in reducing spasticity after one session but shows greater benefit when it is able to be used for multiple sessions. A wearable intensive nerve stimulator (WINS) device has been shown to be safe for daily wear which makes it a feasible solution to address spasticity at home. Research has not yet looked at the efficacy of using the WINS device for spasticity and this study proposes to begin to fill that gap. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04130295
Study type	Interventional
Source	Shepherd Center, Atlanta GA
Contact
Status	Completed
Phase	N/A
Start date	October 15, 2019
Completion date	March 25, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms