Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study

Recruiting N/A Interventional Study
ALS - Amyotrophic Lateral Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
PathMaker Neurosystems Inc. · Industry
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About This Trial
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 foll…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 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 3. Less than or equal to 3 years since ALS symptom onset 4. Slow Vital Capacity ≥ 50% of pre…
Contacts

Seward Rutkove (Clinical Site PI), M.D.

617-667-3069

mhemme@bidmc.harvard.edu

CONTACT

Nader Yaghoubi (Study PI), M.D., Ph.D.

617-535-7696

nyaghoubi@pmneuro.com

CONTACT