Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Physical exams
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
The CALM study tests the MyoRegulator device in adults with ALS, a disease that harms nerves that control muscles. It will gather early information about safety and how well the device may work, with longer follow-up than the earlier study.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–80 years old and have a qualifying ALS diagnosis, whether or not ALS runs in your family.
- Have had ALS symptoms for 3 years or less.
- Have a breathing test result of at least 50% of the expected level and a median nerve muscle-response test result of at least 1.5 mV for TTNCS.
- Score at least 35 on the ALSFRS-R, a scale that measures daily abilities.
- Agree to avoid botulinum toxin, phenol or alcohol injections, baclofen given into spinal fluid, digitalis, and morphine during the study.
- Agree not to join another ALS treatment trial or use another experimental ALS product during the study.
- Women must be unable to become pregnant or use adequate birth control during the study and for 3 months afterward.
- Have stable doses of the listed ALS and muscle spasm or cramp medicines for at least 30 days before starting, and be willing and able to give informed consent.
Who can't join
- Use a breathing machine for more than 22 hours a day for more than 7 days in a row.
- Have ALS signs only in muscles used for speech and swallowing.
- Have a pump that delivers medicine into spinal fluid, or have had botulinum toxin injections within 12 weeks or phenol or alcohol injections for muscle stiffness within 6 months.
- Have damaged skin where stimulation will be given.
- Have certain powered implants or electrically sensitive support devices, except loop recorders; or magnetic metal in the head, neck, or stimulation area. Dental fillings are allowed, but jewelry must be removed.
- Have had seizures or unexplained loss of consciousness in the past 12 months, or have a heart problem that electrical stimulation across the chest could worsen.
- Have spinal cord damage, brain damage, a stroke in the brain’s outer layer, or past spine or brain surgery that the study doctor says could interfere with testing.
- Have a health condition that prevents study testing, or be pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 3 years 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 TTNCS: Median CMAP ≥ 1.5 mV 6. Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the study duration 7. Willing to refrain from participation in any other therapeutic clinical trial or investigational product for ALS for the duration of this study 8. 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. 9. 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 10. ALS Functional Rating Score (ALSFRS-R) of greater than or equal to 35 11. Willing and able to give informed consent Exclusion Criteria: 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)
Study sites (1)
MA
- Beth Israel Deaconess Medical Center · Boston, MA 02215Tatyana Okanlomo · Study contact · 617-667-3083 · tokanlom@bidmc.harvard.eduSeward Rutkove, M.D. · Principal investigatorCourtney McIlduff, M.D., MMSc · Sub-investigatorMore trials in Boston