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Procedure

Direct Current Stimulation 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

18-80 years of age inclusive

Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS as defined by revised El Escorial criteria

Must not have

Study participants who are on permanent assisted ventilation (PAV) defined as >22h of noninvasive or invasive ventilation a day for > 7 consecutive days

Study participants who have been diagnosed with ALS having only clinical bulbar involvement

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

"This trial will assess the MyoRegulator® device for treating ALS in more patients. It aims to gather more information on the safety and effectiveness of the device over a longer period before starting a larger

Who is the study for?

This trial is for individuals with ALS, a type of motor neuron disease. Participants should have completed the previous MyoRegulator® device study (NCT06165172) and are now part of an expanded group to further assess treatment feasibility with longer follow-up.

What is being tested?

The CALM study tests the MyoRegulator® device's safety and potential effectiveness in treating ALS. It's a single-arm study, meaning all participants receive the actual intervention without a comparison group receiving a placebo.

What are the potential side effects?

Specific side effects aren't listed here, but generally, direct current stimulation can sometimes cause skin irritation at the electrode sites or discomfort during treatment.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 80 years old.

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I have been diagnosed with ALS.

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I agree not to use certain medications like botulinum toxin or morphine during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use a ventilator for more than 22 hours a day for over a week.

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My ALS affects only my speech and swallowing.

Timeline

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

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

0 / 5Eligibility criteria met