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NCT04942938 · ClinicalTrials.gov registry record · NA
Impact of Direct Current Electrical Stimulation on Spasticity Levels and Functional Muscle Use in MS
A NA study of Multiple Sclerosis, sponsored by CommonSpirit Health.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT04942938: Completed NA study of Multiple Sclerosis, sponsored by CommonSpirit Health.
NCT04942938 is a NA study of Multiple Sclerosis that has completed, run by CommonSpirit Health. The registered enrollment target is 7 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04942938, a NA study of Multiple Sclerosis, has completed, sponsored by CommonSpirit Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The neurologist did not measure any change in EDSS score for any of the 7 study subjects from her first
Conditions Studied
Interventions
- DEVICE Neubie
Study Locations (1)
Colorado
- Centura Health at Home - Littleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-06-20 |
| Est. Completion | 2022-07-05 |
| Phase | NA |
What the finished NCT04942938 record still lists
NCT04942938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Neubie is the first listed.
NCT04942938 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04942938 about?
NCT04942938 is a clinical study titled "Impact of Direct Current Electrical Stimulation on Spasticity Levels and Functional Muscle Use in MS". 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...
What is the current status of trial NCT04942938?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2021-06-20. Estimated completion is 2022-07-05.
What conditions does trial NCT04942938 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT04942938?
The interventions under investigation include: Neubie (DEVICE).
Who is sponsoring clinical trial NCT04942938?
This trial is sponsored by CommonSpirit Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04942938 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04942938's enrollment target sits among peer trials
7 310th of 315 higher than 5 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis 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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