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NCT03411863 · ClinicalTrials.gov registry record · NA
Cervical Electrical Stimulation for ALS
A NA study of Amyotrophic Lateral Sclerosis, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03411863: Completed NA study of Amyotrophic Lateral Sclerosis, sponsored by VA Office of Research and Development.
NCT03411863 is a NA study of Amyotrophic Lateral Sclerosis that has completed, run by VA Office of Research and Development. The registered enrollment target is 19 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03411863, a NA study of Amyotrophic Lateral Sclerosis, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Veterans are at higher risk than non-Veterans of falling ill with amyotrophic lateral sclerosis (ALS). ALS causes degeneration of motor neurons in both the brain and the spinal cord. Evidence from studies in people with spinal cord injury suggests that activating spared nerve circuits with electromagnetic stimulation improves nerve transmission. With this goal, the investigators have developed a novel method of noninvasive cervical (neck) electrical stimulation (CES). In this study, the investigators will investigate CES for its potential to strengthen nerve circuits to the hands in ALS. To the investigators' knowledge, electrical spinal stimulation for ALS has never been tested previously. This study will be performed in two stages: First, basic experiments will be performed to better understand how CES interacts with other types of electrical and magnetic stimulations over the brain and peripheral nerves. Second, experiments will be performed to determine the types of CES that can facilitate active arm and hand movements. These experiments will improve understanding of electrical stimulation in ALS, and may set the table for future treatments. Both United States Veterans and non-Veterans are eligible to participate in this study.
Primary Outcome
These results are derived from peak-to-peak EMG amplitude in the abductor pollicis brevis (APB) muscle in response to transcranial magnetic stimulation (TMS). Values represent the ratio of peak-to-peak APB amplitude when TMS is paired with cervical electrical stimulation (CES) at the indicated timing (in milliseconds) normalized to the response to TMS alone (control).
Conditions Studied
Interventions
- DEVICE CES at rest
- DEVICE CES plus active hand or wrist movements
Study Locations (1)
New York
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-01-04 |
| Est. Completion | 2021-06-01 |
| Phase | NA |
What the finished NCT03411863 record still lists
NCT03411863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which CES at rest is the first listed.
NCT03411863 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03411863 about?
NCT03411863 is a clinical study titled "Cervical Electrical Stimulation for ALS". Veterans are at higher risk than non-Veterans of falling ill with amyotrophic lateral sclerosis (ALS). ALS causes degeneration of motor neurons in both the brain and the spinal cord. Evidence from studies in people with spinal cord injury suggests that activating spared nerve circuits with electroma...
What is the current status of trial NCT03411863?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2018-01-04. Estimated completion is 2021-06-01.
What conditions does trial NCT03411863 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT03411863?
The interventions under investigation include: CES at rest (DEVICE), CES plus active hand or wrist movements (DEVICE).
Who is sponsoring clinical trial NCT03411863?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03411863 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03411863's enrollment target sits among peer trials
19 81st of 102 higher than 22 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral 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.
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