Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Brief Title:
EIM Via the Myolex mScan as an ALS Biomarker
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ElectricALS
Brief Summary:
Amyotrophic lateral sclerosis ALS has been traditionally considered incurable and untreatable But starting in the 1990s with the introduction of Riluzole therapies are being discovered and ultimately approved for slowing disease progression Many pharmaceutical companies continue to seek new therapeutic approaches One critical aspect of all clinical trials is the need track to progression sensitively to identify the impact of therapy Tools to track ALS progression must be convenient objective require minimal training be easily standardized cost-efficient and have the potential to be applied effectively at home There has been a push to identify accurate objective biomarkers of ALS progression In this study the investigators propose to use Electrical impedance myography EIM to evaluate the progression of the disease Work has shown that the EIM 50 kilohertz kHz phase value from one or more muscles followed sequentially can serve as an effective overall biomarker for assessing the rate of ALS progression for a single person
Detailed Description:
Amyotrophic lateral sclerosis ALS has been traditionally considered incurable and untreatable But starting in the 1990s with the introduction of Riluzole therapies are being discovered and ultimately approved for slowing disease progression Given ALSs uniquely devastating nature the fact that it is considered an orphan disease and uncertainties about its complex pathogenesis many pharmaceutical companies continue to seek new therapeutic approaches In fact despite a relatively poor track record of success there are a plethora of new studies starting up or planned in the near future One critical aspect of all clinical trials is the need track to progression sensitively to identify the impact of therapy Tools to track ALS progression must be convenient objective ie not influenced by patient or evaluator mood or engagement require minimal training be easily standardized and be cost-efficient Moreover ideally such measures also called biomarkers could also be used flexibly for improving individual patient care and could be applied effectively at home Most ALS studies over the past two decades have relied on the ALS functional rating scale-revised ALSFRS-R Yet it is relatively insensitive to change altering on average less than 1 point per month and requiring a large sample size to detect a drug effect as demonstrated by several recent trials that have used it There has been a push to identify accurate objective biomarkers of ALS progression In this study the investigators propose to use Electrical impedance myography EIM to evaluate the progression of the disease Work has shown that the EIM 50 kHz phase value from one or more muscles followed sequentially can serve as an effective overall biomarker for assessing the rate of ALS progression for a single person
Aim 1 To evaluate the sensitivity of EIM 50 kHz phase values to ALS progression as measured by the Myolex mScan device such that it may be able to serve as a monitoring prognostic or pharmacodynamic biomarker in future studies of ALS
Aim 2 To evaluate the potential for additional at-home assessments to improve sensitivity to changedeterioration in ALS and to assess general acceptability to patientscaregivers of doing these measurements at home
Aim 3 To utilize the full set of multifrequency parameters to assess disease progression overtime via the application of machine learning analytics to increase the power of EIM as an ALS biomarker
Aim 1 To evaluate the sensitivity of EIM 50 kHz phase values to ALS progression as measured by the Myolex mScan device such that it may be able to serve as a monitoring prognostic or pharmacodynamic biomarker in future studies of ALS
Aim 2 To evaluate the potential for additional at-home assessments to improve sensitivity to changedeterioration in ALS and to assess general acceptability to patientscaregivers of doing these measurements at home
Aim 3 To utilize the full set of multifrequency parameters to assess disease progression overtime via the application of machine learning analytics to increase the power of EIM as an ALS biomarker
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HT9425-24-1-0650 | OTHER_GRANT | None | None |