EIM Via the Myolex mScan as an ALS Biomarker

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT06491732
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electrical Impedance Myography — DEVICE
    EIM is an impedance-based technology in which an imperceptible, high-, multi-frequency (e.g., 1 kHz to 10 MHz) electrical current is applied across two electrodes; the resulting voltage signals are measured across two sense electrodes

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Apr 2026
Primary completion
May 30, 2027
Completion
May 30, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Amyotrophic Lateral Sclerosis
    Patients diagnosed with ALS

Primary Outcome Measure

EIM phase change over time [ Time Frame: 8 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013
Kathleen Nagaran Hildebrand
[email protected]
Shafeeq Ladha, MD (PRINCIPAL_INVESTIGATOR)
Jourdan Milliard (SUB_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Giulia Cenci
[email protected]
617-667-3056
Seward Rutkove, MD (PRINCIPAL_INVESTIGATOR)
Masumeh Hatami, MD (SUB_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02110
Lindy Feintuch
[email protected]
Sabrina Paganoni, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Jayna Duell
[email protected]
734-936-8775
Alyssa Braun
[email protected]
Stephen Goutman, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03766
Gina Kersey
[email protected]
603-650-5398
Elijah Stommel, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mark Garret, MD (SUB_INVESTIGATOR)
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Zachary Chandler
[email protected]
336-713-3039
Jim Caress, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Barrow Neurological Institute· Phoenix, AZBeth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Michigan· Ann Arbor, MIDartmouth Hitchcock Medical Center· Lebanon, NHAtrium Health Wake Forest Baptist Medical Center· Winston-Salem, NC

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