CALM Study: MyoRegulator® for ALS
This study, called CALM, is looking at a device called MyoRegulator® for people with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. The MyoRegulator® uses multi-site direct current stimulation (DCS) to help control overactive motor neurons, which are nerve cells that control movement, and activate pathways that break down proteins. We are looking for about 15 participants aged 18 to 80 who have been diagnosed with ALS within the last three years and have good lung function. The main goals are to see if the MyoRegulator® treatment is practical to use and safe, by tracking any side effects for up to six months after treatment. This study builds on previous research to gather more information before a larger study.
- Study design
- This is an interventional study with a planned enrollment of 15 participants. It is a single-arm study, meaning all participants will receive the MyoRegulator® treatment.
- What's involved
- Participants will receive the MyoRegulator® treatment on a specific day and have follow-up visits for up to 3 months post-treatment to check feasibility, and up to 6 months post-treatment to monitor safety.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for feasibility for up to 3 months post-treatment and for safety for up to 6 months post-treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
At a glance
Conditions
NCT06649955
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Beth Israel Deaconess Medical Center
Boston, Massachusettsstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Feasibility of treating ALS patients using multi-site DCSOn treatment day and at each follow-up visit out to 3 months post-treatment
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:
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]On treatment day and at each follow-up visit out to 6 months post-treatment
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.