NCT06165172

Early Feasibility Study of the MyoRegulator® for Treatment of ALS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: PathMaker Neurosystems Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease) is a progressive neurodegenerative disease that affects motor neurons in spinal cord and brain. ALS causes motor and cognitive function deficits and eventual death, typically within 2-5 years of diagnosis. There are at least 30,000 ALS patients in the United States and about 5,000 new diagnoses every year according to the Centers for Disease Control (CDC). Recent research has established important links between ALS and motor neuron hyperexcitability and suggest that motor neuron hyperexcitability is found across different ALS variants. The multi-site DCS MyoRegulator® treatment is a non-invasive approach to the suppression of motor neuron hyperexcitability based on multi-site direct current stimulation (DCS). Pre-clinical studies show that treatment using multi-site DCS effectively slows disease progression in transgenic mouse models of ALS. This is associated with improved motor function, preservation of motor neurons, and improved animal survival. This clinical study is a non-significant risk (NSR) investigation using the non-invasive multi-site DCS MyoRegulator® to evaluate the feasibility and safety of treatment with MyoRegulator® in individuals with ALS. The primary endpoint is feasibility and safety. Feasibility will be evaluated by recording and assessing the proportion potential participants who are enrolled from the total number of participants screened for the study, the ease of delivering treatment, the tolerability of study participants to the treatment, and the compliance of study participants with the study schedule and evaluations. 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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DEVICE	MyoRegulator®	Study participants will receive treatment using the MyoRegulator® device 3 times a week for 2 x 30 minutes per session. The first week of treatment will be followed by a 1-week rest period with no treatments. Treatment sessions will then resume for 4 consecutive weeks, 3 times per week. A follow-up visit will be scheduled 4 weeks after the last treatment session.

Timeline

• Start date: 2023-06-21
• Primary completion: 2024-07-31
• Completion: 2024-08-31
• First posted: 2023-12-11
• Last updated: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study