๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-16

Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study (NCT06649955)

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: PathMaker Neurosystems Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

Following completion of the ALS Early Feasibility Study of the MyoRegulatorยฎ device for treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the MyoRegulatorยฎ 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: Review the eligibility criteria below.

Location: Beth Israel Deaconess Medical Center โ€” Boston, Massachusetts

Age range: 18 Years to 80 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Beth Israel Deaconess Medical Center โ€” Boston, Massachusetts

๐Ÿ“ž Contact the Study Coordinator

Phone: (617) 667-3069

Email: mhemme@bidmc.harvard.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

More studies in ALS - Amyotrophic Lateral Sclerosis

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—