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NCT06649955 · ClinicalTrials.gov registry record · NA
Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
A NA study of ALS (Amyotrophic Lateral Sclerosis), sponsored by PathMaker Neurosystems.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06649955: Recruiting NA study of ALS (Amyotrophic Lateral Sclerosis), sponsored by PathMaker Neurosystems.
NCT06649955 is a NA study of ALS (Amyotrophic Lateral Sclerosis) that is actively recruiting participants, run by PathMaker Neurosystems. The registered enrollment target is 15 participants, below the 365-participant average among 6 other ALS (Amyotrophic Lateral Sclerosis) trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06649955, a NA study of ALS (Amyotrophic Lateral Sclerosis), is actively recruiting participants, sponsored by PathMaker Neurosystems.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the MyoRegulator® device to treat ALS in an expanded number of individuals with ALS. CALM will gather additional preliminary evidence of clinical safety and potential effectiveness in this patient population with a longer follow-up period and additional secondary endpoints in a single-arm study prior to commencing a larger sham-controlled pivotal trial.
Primary Outcome
The feasibility of treating ALS patients using multi-site DCS will be evaluated by determining the number of patients who can complete all of the study treatments at the target stimulation levels:
Conditions Studied
Interventions
- DEVICE Multi-site direct current stimulation (DCS)
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-02-10 |
| Est. Completion | 2026-11 |
| Phase | NA |
What NCT06649955 shows while recruiting
NCT06649955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 365-participant average among 6 other ALS (Amyotrophic Lateral Sclerosis) trials with a reported enrollment target (96% lower).
The record links to 1 condition, with ALS (Amyotrophic Lateral Sclerosis) appearing as the primary indexed condition, and to 1 intervention - of which Multi-site direct current stimulation (DCS) is the first listed.
NCT06649955 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06649955 about?
NCT06649955 is a clinical study titled "Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study". Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the MyoRegulator® device to treat ALS in an expanded number of individuals with ALS. CALM will gather additional preliminary e...
What is the current status of trial NCT06649955?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-02-10. Estimated completion is 2026-11.
What conditions does trial NCT06649955 study?
This clinical trial studies the following conditions: ALS (Amyotrophic Lateral Sclerosis).
What interventions are being tested in trial NCT06649955?
The interventions under investigation include: Multi-site direct current stimulation (DCS) (DEVICE).
Who is sponsoring clinical trial NCT06649955?
This trial is sponsored by PathMaker Neurosystems, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06649955 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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