CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Neubiedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04942938
NCT04942938N/ACompleted

A Pilot Study of Neubie, a Direct Current Electrical Stimulation Device, to Inhibit Lower Extremity Spasticity Levels and Normalize Muscle Functional Use During Transfers and Ambulation in Individuals With Multiple Sclerosis

CommonSpirit Health·interventional·Posted Jun 29, 2021·Updated Jul 4, 2025

In Brief

A clinical study evaluating Neubie for Multiple Sclerosis. Completed, enrolled 7 participants across 1 site.

Detailed Summary

In an individual with MS the central nervous system (CNS) is over-protective and causes the threshold for stretch reflex and muscle tightness to be set lower than normal. This inhibits normal movement and causes abnormalities in posture, stiffness and at times joint contractures. In this pilot study we hope to assess the ability for the direct current of Neubie, which creates mechanoreceptor inputs and lengthening at the sarcomere level of muscle and joints in the spine and lower extremity, to alter the proprioceptive peripheral nervous system (PNS) at muscle spindle and GTO level with a change in CNS over-guarding during the treatment and after the treatment. If the investigators are able to create normalized stretch and muscle tension at the PNS level, it may be possible to create temporary or sustained CNS level changes. This would allow the amount of stretch and tension at the PNS level to be normalized and possibly reduce spasticity. If this theory is accurate, the investigators may be able to increase access to normalized movement, strength and functional ability in individuals with neuro-compromise.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 29, 2021
Enrollment StartJun 20, 2021
Primary CompletionJul 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.0 years ago

Interventions

Neubiedevice

The Neubie is a direct current neuromuscular electrical stimulation device. This system uses an exponential wave pattern to mimic the natural pattern neurologically to lengthen fibers of the sarcomere and engage force velocity of muscle with minimized protective co-contraction of nearby muscle groups. The golgi tendon and muscle spindles code for joint position and muscle/tendon stretch with 66% of fibers being intrafusal. Impacting these structures has direct impact on reticulospinal tract fibers and proprioceptive central fibers modulation of levels of spasticity. The Neubie direct current is designed to improve positioning of these stretch receptors.