NCT06165172Completed
Early Feasibility Study of the MyoRegulator® for Treatment of ALS
Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS). This study is the first use of the MyoRegulator® device to treat individuals with ALS. The main objective of this study is to confirm that individuals with ALS can tolerate the study treatment regimen without any evidence of serious adverse events related to the use of the device. The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation. It has been used in two completed clinical trials evaluating its efficacy to treat post-stroke muscle spasticity and is currently being evaluated in a third trial in this post-stroke population.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 28 Nov 2023
- Start date
- 21 Jun 2023
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- PathMaker Neurosystems Inc.
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06165172
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 21 Jun 2023 to the primary completion date, 31 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior botulinum toxin injection(s) within 12 weeks of study enrollment
- Prior phenol or alcohol injections within 6 months of study enrollment
- Past history of epileptic seizures or unexplained spells of loss of consciousness during the previous 36 months
Other illness
- 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
- Any medical condition that would prevent the participant from being able to participate in the clinical outcome measures
Other
- Study participants who are on permanent assisted ventilation (PAV) defined as \>22h of noninvasive or invasive ventilation a day for \> 7 consecutive days.
- Implanted intrathecal pump
- Presence of potential risk factors for trans-spinal direct current stimulation:
- 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.)
- Lack of sensory perception at the stimulation sites
- Ferrous metal in the path of the current flow (jewelry must be removed during stimulation)
- Pregnant females, as determined by a pregnancy test at enrollment (in females of child-bearing potential)
Who the study is looking for
- 18 years of age or older
- A clinical diagnosis of ALS as confirmed by medical history
- 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 clinical trial for the duration of this study
- Willing to forgo pregnancy for the duration of the study
- Willing and able to give informed consent or have informed consent provided for them by their legal guardian
- Cognitive function sufficient to understand the study and follow instructions (per interview with appropriate clinician)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Spaulding Rehabilitation Hospital Coordinator of this site? Confirm its status | Charlestown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.