← Back to Search

Procedure

Active MyoRegulator Treatment Arm for ALS (CALM Trial)

N/A
Waitlist Available
Research Sponsored by PathMaker Neurosystems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. 18-80 years of age inclusive
2. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS as defined by revised El Escorial criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline the day prior to treatment start, after the last treatment at study week 4 and at follow-up during weeks 5, 8, 16, and 28
Awards & highlights
No Placebo-Only Group

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 RCT.

Eligible Conditions
  • ALS

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline the day prior to treatment start, after the last treatment at study week 4 and at follow-up during weeks 5, 8, 16, and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline the day prior to treatment start, after the last treatment at study week 4 and at follow-up during weeks 5, 8, 16, and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of treating ALS patients using multi-site DCS
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary study objectives
ALS Assessment Questionnaire (ALSAQ-40)
ALS Functional Rating Scale (ALSFRS-R)
Accurate Test of Limb Isometric Strength (ATLIS)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active MyoRegulator Treatment ArmExperimental Treatment1 Intervention
4 weeks of active MyoRegulator® device treatment three times per week then follow-up at 1 week, 1 month, 3 months, and optionally at 6 months following the end of treatment

Find a Location

Who is running the clinical trial?

PathMaker Neurosystems Inc.Lead Sponsor
4 Previous Clinical Trials
103 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
853 Previous Clinical Trials
12,930,435 Total Patients Enrolled
~10 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top