Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649955
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALM
Brief Summary:
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 RCT
Detailed Description:
Amyotrophic lateral sclerosis ALS Lou Gehrigs 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 30000 ALS patients in the United States and about 5000 new diagnoses every year according to the Centers for Disease Control CDC
Central features of ALS pathology include the development of motor neuron hyperexcitability and the formation of protein aggregates in the cytoplasmic compartment of motor neurons and these are found across different ALS variants The MyoRegulator treatment is a non-invasive neuromodulation-based intervention that suppresses motor neuron hyperexcitability and activates protein degradation pathways through the use of multi-site direct current stimulation multi-site 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 single-site open-label investigation using the non-invasive multi-site DCS MyoRegulator to evaluate the feasibility and safety of treatment with MyoRegulator in individuals with ALS and to provide initial evidence of efficacy 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
Central features of ALS pathology include the development of motor neuron hyperexcitability and the formation of protein aggregates in the cytoplasmic compartment of motor neurons and these are found across different ALS variants The MyoRegulator treatment is a non-invasive neuromodulation-based intervention that suppresses motor neuron hyperexcitability and activates protein degradation pathways through the use of multi-site direct current stimulation multi-site 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 single-site open-label investigation using the non-invasive multi-site DCS MyoRegulator to evaluate the feasibility and safety of treatment with MyoRegulator in individuals with ALS and to provide initial evidence of efficacy 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None