Actively Recruiting
Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Led by PathMaker Neurosystems Inc. · Updated on 2026-01-20
15
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
Sponsors
P
PathMaker Neurosystems Inc.
Lead Sponsor
B
Beth Israel Deaconess Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years inclusive
- Diagnosed with sporadic or familial ALS as possible, probable, lab-supported probable, or definite ALS by revised El Escorial criteria
- ALS symptom onset within 3 years or less
- Slow Vital Capacity at least 50% of predicted at screening
- Median CMAP at least 1.5 mV for TTNCS
- Willing to avoid botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine during the study
- Willing to not participate in other ALS therapeutic trials or investigational products during the study
- Women must be unable to become pregnant or use effective birth control during the study and for 3 months after
- Stable dose of rilutek, edaravone, tofersen, or muscle spasm medications for at least 30 days prior to participation
- ALS Functional Rating Score (ALSFRS-R) of 35 or higher
- Able and willing to give informed consent
You will not qualify if you...
- Use of permanent assisted ventilation more than 22 hours a day for over 7 consecutive days
- Diagnosis of ALS with only clinical bulbar involvement
- Presence of implanted intrathecal pump
- Botulinum toxin injections within 12 weeks before enrollment
- Phenol or alcohol injections for spasticity within 6 months before enrollment
- Damaged skin at stimulation sites
- Presence of electrically, magnetically, or mechanically activated implants except loop recorders
- Ferromagnetic metal in head, neck, or stimulation sites (except dental fillings); jewelry must be removed during stimulation
- Seizures or unexplained loss of consciousness in past 12 months
- Cardiac abnormalities that could worsen with electrical stimulation
- History of spinal cord lesions or surgery interfering with procedure
- History of brain lesions, stroke, or neurosurgery interfering with TMS as approved by study doctor
- Any medical condition preventing participation in clinical outcome measures
- Pregnant females as confirmed by pregnancy test at initial visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
S
Seward Rutkove (Clinical Site PI), M.D.
CONTACT
N
Nader Yaghoubi (Study PI), M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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