Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study

NCT06649955 | Recruiting FDA Device

• 2 other identifiers: ALS2CDMRP-AL230079
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ALS - Amyotrophic Lateral Sclerosis

Keywords

ALS; Lou Gehrig's disease; Non-invasive; Multi-site direct current stimulation (multi-site DCS)

Outcome Measures

Primary Outcomes (2)

• Feasibility of treating ALS patients using multi-site DCS

  The feasibility of treating ALS patients using multi-site DCS will be evaluated by determining the number of patients who can complete all of the study treatments at the target stimulation levels:

  On treatment day and at each follow-up visit out to 3 months post-treatment

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Safety will be evaluated by recording the frequency and duration of any adverse events reported by study participants or observed by physical examination during or following treatment and throughout the study duration, with particular attention to any device-related serious adverse events or unanticipated adverse events.

  On treatment day and at each follow-up visit out to 6 months post-treatment

Secondary Outcomes (7)

• ALS Functional Rating Scale (ALSFRS-R)

  Just prior to treatment start at study week 1, after the last treatment at study week 4, then during follow-up at study weeks 8, 16, and 28

• Rasch Overall ALS Disability Scale (ROADS)

  Just prior to treatment start at study week 1, after the last treatment at study week 4, then during follow-up at study weeks 8, 16, and 28

• ALS Assessment Questionnaire (ALSAQ-40)

  Just prior to treatment at study week 1, then during follow-up at study weeks 4, 8, 16, and 28

• Accurate Test of Limb Isometric Strength (ATLIS)

  At baseline the day prior to treatment start, after the last treatment at study week 4, and at follow-up during weeks 8, 16, and 28

• Threshold tracking nerve conduction studies (TTNCS)

  At baseline the day prior to treatment start, after the last treatment at study week 4, and at follow-up during weeks 5, 8, 16, and 28

Study Arms (1)

Active MyoRegulator Treatment Arm

EXPERIMENTAL

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

Device: Multi-site direct current stimulation (DCS)

Interventions

Multi-site direct current stimulation (DCS) DEVICE

The MyoRegulator® treatment is a non-invasive intervention that suppresses motor neuron hyperexcitability and activates protein degradation pathways through the use of multi-site direct current stimulation (multi-site DCS).

Active MyoRegulator Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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
• History of cord lesions or previous spinal surgery that may interfere with procedure as determined by the study MD
• History of intracranial brain lesions, cortical stroke or previous neurosurgery that may interfere with TMS (e.g., in regions to be stimulated for TMS evaluations) as reviewed and approved by the study MD
• Any medical condition that would prevent the participant from being able to participate in the clinical outcome measures
• Pregnant females, as determined by a pregnancy test at V1 (in females of child-bearing potential)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: collaborator
• United States Department of Defense: collaborator
• PathMaker Neurosystems Inc.: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

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

CONTACT

617-667-3069; mhemme@bidmc.harvard.edu

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

CONTACT

617-535-7696; nyaghoubi@pmneuro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 21, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)