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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: Completed NA study, sponsored by PathMaker Neurosystems.
NCT06165172 is a NA study that has completed, run by PathMaker Neurosystems. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety will be evaluated by recording the frequency, severity, and duration of any adverse events reported by study participants or observed by physical examination during or following treatment and throughout the study duration.
Interventions
- DEVICE MyoRegulator®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-06-21 |
| Est. Completion | 2024-08-31 |
| Phase | NA |
What the finished NCT06165172 record still lists
NCT06165172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which MyoRegulator® is the first listed.
NCT06165172 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06165172's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 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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