RECRUITING

Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study

Quick Facts

Study Start:2025-02-10

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06649955

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18-80 years of age inclusive 2. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS as defined by revised El Escorial criteria 3. Less than or equal to 24 months since ALS symptom onset 4. Slow Vital Capacity ≥ 50% of predicted capacity at the time of Screening as determined using a portable spirometer 5. 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) 6. For TTNCS: Median CMAP ≥ 1.5 mV 7. Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the study duration 8. Willing to refrain from participation in any other therapeutic clinical trial or investigational product for ALS for the duration of this study 9. 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. 10. 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 11. ALS Functional Rating Score (ALSFRS-R) of greater than or equal to 35 12. Willing and able to give informed consent	1. Study participants who are on permanent assisted ventilation (PAV) defined as \>22h of noninvasive or invasive ventilation a day for \> 7 consecutive days. 2. Study participants who have been diagnosed with ALS having only clinical bulbar involvement 3. Implanted intrathecal pump 4. Prior botulinum toxin injection(s) at any site within 12 weeks of study enrollment 5. Prior phenol or alcohol injections for spasticity within 6 months of study enrollment 6. Presence of potential tsDCS and/or TMS risk factors: 1. 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.) 2. 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 3. 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 4. Seizures or unexplained spells of loss of consciousness during the previous 12 months 5. Any cardiac abnormality that may be exacerbated by transthoracic electrical stimulation 6. History of cord lesions or previous spinal surgery that may interfere with procedure as determined by the study MD 7. 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 7. Any medical condition that would prevent the participant from being able to participate in the clinical outcome measures 8. Pregnant females, as determined by a pregnancy test at V1 (in females of child-bearing potential)

Inclusion Criteria

Exclusion Criteria

1. 18-80 years of age inclusive
2. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS as defined by revised El Escorial criteria
3. Less than or equal to 24 months since ALS symptom onset
4. Slow Vital Capacity ≥ 50% of predicted capacity at the time of Screening as determined using a portable spirometer
5. 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)
6. For TTNCS: Median CMAP ≥ 1.5 mV
7. Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the study duration
8. Willing to refrain from participation in any other therapeutic clinical trial or investigational product for ALS for the duration of this study
9. 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.
10. 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
11. ALS Functional Rating Score (ALSFRS-R) of greater than or equal to 35
12. Willing and able to give informed consent

1. Study participants who are on permanent assisted ventilation (PAV) defined as \>22h of noninvasive or invasive ventilation a day for \> 7 consecutive days.
2. Study participants who have been diagnosed with ALS having only clinical bulbar involvement
3. Implanted intrathecal pump
4. Prior botulinum toxin injection(s) at any site within 12 weeks of study enrollment
5. Prior phenol or alcohol injections for spasticity within 6 months of study enrollment
6. Presence of potential tsDCS and/or TMS risk factors:
1. 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.)
2. 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
3. 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
4. Seizures or unexplained spells of loss of consciousness during the previous 12 months
5. Any cardiac abnormality that may be exacerbated by transthoracic electrical stimulation
6. History of cord lesions or previous spinal surgery that may interfere with procedure as determined by the study MD
7. 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
7. Any medical condition that would prevent the participant from being able to participate in the clinical outcome measures
8. Pregnant females, as determined by a pregnancy test at V1 (in females of child-bearing potential)

Contacts and Locations

Study Contact

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 Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: PathMaker Neurosystems Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-10

Study Completion Date2026-11

Study Record Updates

Study Start Date2025-02-10

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

ALS - Amyotrophic Lateral Sclerosis