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NCT04130295 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Shepherd Center, Atlanta GA.

Completed
Registry status
NA
Development phase
12
Enrollment target

NCT04130295: Completed NA study, sponsored by Shepherd Center, Atlanta GA.

NCT04130295 is a NA study that has completed, run by Shepherd Center, Atlanta GA. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04130295, a NA study, has completed, sponsored by Shepherd Center, Atlanta GA.

COMPLETED
Registry status
NA
Development phase
12 participants
Enrollment target

Study 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.

Primary Outcome

Instrumented Pendulum Test: Participants will be in a semi-reclined position on a therapy mat. The examiner will then bring the participants knee into full extension before dropping the foot. The examiner will observe the number of oscillations to determine muscle stretch-induced activity

Interventions

  • OTHER Wearable intensive nerve stimulator

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2019-10-15
Est. Completion 2021-03-25
Phase NA
Shepherd Center, Atlanta GA

17 total trials

What the finished NCT04130295 record still lists

NCT04130295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Wearable intensive nerve stimulator is the first listed.

NCT04130295 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04130295 about?

NCT04130295 is a clinical study titled "Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury". 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...

What is the current status of trial NCT04130295?

This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2019-10-15. Estimated completion is 2021-03-25.

What interventions are being tested in trial NCT04130295?

The interventions under investigation include: Wearable intensive nerve stimulator (OTHER).

Who is sponsoring clinical trial NCT04130295?

This trial is sponsored by Shepherd Center, Atlanta GA, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04130295's enrollment target sits among peer trials

12 1913th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04130295, the US trial registry maintained by the National Library of Medicine. NCT04130295 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.