Recruiting

ALS Biomarker

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06491732

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electrical Impedance Myography

Study Details

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.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT06491732

Start date

Mar 1, 2025

Status verified date

Apr, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria
  • Capable of providing informed consent and complying with study procedures in the investigator's opinion
  • Time since ALS symptom onset ≤36 months
  • Vital Capacity of ≥40% of predicted capacity as measured by forced vital capacity or slow vital capacity
  • Must have a study partner for home visits
  • Access to the internet for data upload
  • Age 18 years or older

Exclusion Criteria:

  • Clinically significant unstable medical condition (other than ALS) that would affect the participant's ability to participate, according to the investigator's judgment
  • Patient with pure upper motor neuron disease (PLS)
  • Known history of unstable psychiatric disease, cognitive impairment, dementia, or active substance abuse
  • Significant pitting edema (2+ or more) that would interfere with EIM measures
  • Active cancer or history of cancer treated with chemotherapy and/or radiation
  • BMI >35

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Amyotrophic Lateral Sclerosis

Patients diagnosed with ALS

Interventions

Electrical Impedance Myography

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Giulia Cenci

617-667-3056gcenci@bidmc.harvard.edu

Locations

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Kathleen Nagaran Hildebrand

fulton.research@commonspirit.org

Principal Investigator:

Shafeeq Ladha, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02110

Contacts

Lindy Feintuch

lfeintuch@mgh.harvard.edu

Principal Investigator:

Sabrina Paganoni, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Giulia Cenci

617-667-3056gcenci@bidmc.harvard.edu

Principal Investigator:

Seward Rutkove, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jayna Duell

734-936-8775jkballar@med.umich.edu

Alyssa Braun

alybra@med.umich.edu

Principal Investigator:

Stephen Goutman, MD

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Gina Kersey

603-650-5398gina.e.kersey@hitchcock.org

Principal Investigator:

Elijah Stommel, MD, PhD

Atrium Health Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Zachary Chandler

336-713-3039zachary.chandler@advocatehealth.org

Principal Investigator:

Jim Caress, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Amyotrophic Lateral Sclerosis
  • Electrical Impedance Myography
  • Biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-04-22.