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NCT06165172 · ClinicalTrials.gov registry record · NA
Early Feasibility Study of the MyoRegulator® for Treatment of ALS
A NA study, sponsored by PathMaker Neurosystems.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT06165172 is a NA study that has completed, run by PathMaker Neurosystems. The registered enrollment target is 5 participants.
The verdict
NCT06165172, a NA study, has completed, sponsored by PathMaker Neurosystems.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS). This study is the first use of the MyoRegulator® device to treat individuals with ALS. The main objective of this study is to confirm that individuals with ALS can tolerate the study treatment regimen without any evidence of serious adverse events related to the use of the device. The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation. It has been used in two completed clinical trials evaluating its efficacy to treat post-stroke muscle spasticity and is currently being evaluated in a third trial in this post-stroke population.
Interventions
- DEVICE MyoRegulator®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-06-21 |
| Est. Completion | 2024-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06165172
The ClinicalTrials.gov registry entry for NCT06165172 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PathMaker Neurosystems, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MyoRegulator® is the first listed.
NCT06165172 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06165172 about?
NCT06165172 is a clinical study titled "Early Feasibility Study of the MyoRegulator® for Treatment of ALS". This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS). This study is the first use of the MyoRegulator® device to treat individuals with ALS. The main objec...
What is the current status of trial NCT06165172?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2023-06-21. Estimated completion is 2024-08-31.
What interventions are being tested in trial NCT06165172?
The interventions under investigation include: MyoRegulator® (DEVICE).
Who is sponsoring clinical trial NCT06165172?
This trial is sponsored by PathMaker Neurosystems, which has 3 total clinical trials registered on ClinicalTrials.gov.
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