Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study (NCT06649955)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (16 items).
Location: Beth Israel Deaconess Medical Center — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
- Implanted intrathecal pump
- Prior botulinum toxin injection(s) at any site within 12 weeks of study enrollment
- Prior phenol or alcohol injections for spasticity within 6 months of study enrollment
- Presence of potential tsDCS and/or TMS risk factors:
- Damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
- Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker) or any other electrically sensitive support system with the exception of loop recorders
- Ferromagnetic metal in the head, neck or any site of stimulation including, but not limited to, aneurysm clips, implanted medication pumps, implanted brain stimulators, pacemakers, cochlear implants, implanted metal prostheses or metal due to any injury; dental fillings are permitted. Jewelry must be removed during stimulation
- Seizures or unexplained spells of loss of consciousness during the previous 12 months
- Any cardiac abnormality that may be exacerbated by transthoracic electrical stimulation
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.