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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 belowTimeline
Screening ~ 3 weeks3 visits
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
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
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 moreAwards & 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
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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
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