Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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

• Less than or equal to 3 years since ALS symptom onset

• Slow Vital Capacity ≥ 50% of predicted capacity at the time of Screening as determined using a portable spirometer

• For TMS: a resting motor threshold, (defined as the minimum intensity to elicit a motor evoked potential (MEP) of amplitude ≥ 50 μV from at least 5 of 10 consecutive pulses)

• For TTNCS: Median CMAP ≥ 1.5 mV

• Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the study duration

• Willing to refrain from participation in any other therapeutic clinical trial or investigational product for ALS for the duration of this study

• Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and 3 months after study completion.

⁃ Stable dose of rilutek (Riluzole), edaravone (Radicava), or tofersen (Qualsody) and oral medications for muscle spasms/cramps (e.g. mexiletine, quinine, quinidine, magnesium, gabapentin, oxcarbazepine, baclofen) for at least 30 days prior to the onset of participation in the study

⁃ ALS Functional Rating Score (ALSFRS-R) of greater than or equal to 35

⁃ Willing and able to give informed consent

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Seward Rutkove (Clinical Site PI), M.D.
mhemme@bidmc.harvard.edu
617-667-3069
Backup
Nader Yaghoubi (Study PI), M.D., Ph.D.
nyaghoubi@pmneuro.com
617-535-7696
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2026-11
Participants
Target number of participants: 15
Treatments
Experimental: Active MyoRegulator Treatment Arm
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
Sponsors
Collaborators: United States Department of Defense, Beth Israel Deaconess Medical Center
Leads: PathMaker Neurosystems Inc.

This content was sourced from clinicaltrials.gov