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Amyotrophic Lateral SclerosisElectricALSNCT06491732

EIM Via the Myolex mScan as an ALS Biomarker

An observational study of Amyotrophic Lateral Sclerosis, run by Beth Israel Deaconess Medical Center at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
Electrical Impedance Myography
Type of treatment
Medical device
How many people
80 participants
Where
6 sitesUnited States
Study dates
1 Mar 2025to 30 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with ALS

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Giulia Cenci contact

617-667-3056

gcenci@bidmc.harvard.edu

6 sites in 1 country

United States6 sites, 6 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Jayna Duell, 734-936-8775, jkballar@med.umich.edu

    Alyssa Braun, alybra@med.umich.edu

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02110

    Lindy Feintuch, lfeintuch@mgh.harvard.edu

    Sabrina Paganoni, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Giulia Cenci, 617-667-3056, gcenci@bidmc.harvard.edu

    Seward Rutkove, MD

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Gina Kersey, 603-650-5398, gina.e.kersey@hitchcock.org

    Elijah Stommel, MD, PhD

    Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

    Kathleen Nagaran Hildebrand, fulton.research@commonspirit.org

    Shafeeq Ladha, MD

    Recruiting

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Zachary Chandler, 336-713-3039, zachary.chandler@advocatehealth.org

    Jim Caress, MD

    Recruiting

Other trials in United States

About this study

Official title: Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker

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.

Read the 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 ALS's 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 (i.e. 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 change/deterioration in ALS and to assess general acceptability to patients/caregivers 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.

Being tested
Electrical Impedance Myography
Keywords
Amyotrophic Lateral Sclerosis, Electrical Impedance Myography, Biomarker
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrical Impedance MyographyDevice

    Also called Myolex mScan

    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 groups in NCT06491732
Study groupRoleWhat they receive
Amyotrophic Lateral SclerosisPatients diagnosed with ALS
Receives: Device: Electrical Impedance Myography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EIM phase change over time

    Mean and standard deviation in rate of change in EIM phase values compared to mean and standard deviation in rate of change in ALSFRS-R over 8 months

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start1 Mar 2025
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491732
Sponsor's protocol ID
2024P000292
Other IDs
HT9425-24-1-0650
Acronym
ElectricALS
Status last verified
Apr 2026
First submitted
1 Jul 2024
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All de-identified data will be shared publicly through existing websites (such as the Pooled Resource Open-Access ALS Clinical Trials database). We will include relevant clinical and demographic information (all de-identified). The Digital Object Identifier (DOI) will be referenced in any publication to allow the research community easy access to the exact data used in the publication. The results of the study will also be shared via publication in open-access journals and at national and international ALS meetings (e.g., at the international ALS Motor Neuron Diseases meeting).

Publications

  • Bowser R, Cudkowicz M, Kaddurah-Daouk R. Biomarkers for amyotrophic lateral sclerosis. Expert Rev Mol Diagn. 2006 May;6(3):387-98. doi: 10.1586/14737159.6.3.387.

    PubMed 16706741

  • Mancuso R, Navarro X. Amyotrophic lateral sclerosis: Current perspectives from basic research to the clinic. Prog Neurobiol. 2015 Oct;133:1-26. doi: 10.1016/j.pneurobio.2015.07.004. Epub 2015 Aug 5.

    PubMed 26253783

  • Malik R, Lui A, Lomen-Hoerth C. Amyotrophic lateral sclerosis. Semin Neurol. 2014 Nov;34(5):534-41. doi: 10.1055/s-0034-1396007. Epub 2014 Dec 17.

    PubMed 25520025

  • DeJesus-Hernandez M, Mackenzie IR, Boeve BF, Boxer AL, Baker M, Rutherford NJ, Nicholson AM, Finch NA, Flynn H, Adamson J, Kouri N, Wojtas A, Sengdy P, Hsiung GY, Karydas A, Seeley WW, Josephs KA, Coppola G, Geschwind DH, Wszolek ZK, Feldman H, Knopman DS, Petersen RC, Miller BL, Dickson DW, Boylan KB, Graff-Radford NR, Rademakers R. Expanded GGGGCC hexanucleotide repeat in noncoding region of C9ORF72 causes chromosome 9p-linked FTD and ALS. Neuron. 2011 Oct 20;72(2):245-56. doi: 10.1016/j.neuron.2011.09.011. Epub 2011 Sep 21.

    PubMed 21944778

  • Renton AE, Majounie E, Waite A, Simon-Sanchez J, Rollinson S, Gibbs JR, Schymick JC, Laaksovirta H, van Swieten JC, Myllykangas L, Kalimo H, Paetau A, Abramzon Y, Remes AM, Kaganovich A, Scholz SW, Duckworth J, Ding J, Harmer DW, Hernandez DG, Johnson JO, Mok K, Ryten M, Trabzuni D, Guerreiro RJ, Orrell RW, Neal J, Murray A, Pearson J, Jansen IE, Sondervan D, Seelaar H, Blake D, Young K, Halliwell N, Callister JB, Toulson G, Richardson A, Gerhard A, Snowden J, Mann D, Neary D, Nalls MA, Peuralinna T, Jansson L, Isoviita VM, Kaivorinne AL, Holtta-Vuori M, Ikonen E, Sulkava R, Benatar M, Wuu J, Chio A, Restagno G, Borghero G, Sabatelli M; ITALSGEN Consortium; Heckerman D, Rogaeva E, Zinman L, Rothstein JD, Sendtner M, Drepper C, Eichler EE, Alkan C, Abdullaev Z, Pack SD, Dutra A, Pak E, Hardy J, Singleton A, Williams NM, Heutink P, Pickering-Brown S, Morris HR, Tienari PJ, Traynor BJ. A hexanucleotide repeat expansion in C9ORF72 is the cause of chromosome 9p21-linked ALS-FTD. Neuron. 2011 Oct 20;72(2):257-68. doi: 10.1016/j.neuron.2011.09.010. Epub 2011 Sep 21.

    PubMed 21944779

  • Gurney ME, Pu H, Chiu AY, Dal Canto MC, Polchow CY, Alexander DD, Caliendo J, Hentati A, Kwon YW, Deng HX, et al. Motor neuron degeneration in mice that express a human Cu,Zn superoxide dismutase mutation. Science. 1994 Jun 17;264(5166):1772-5. doi: 10.1126/science.8209258.

    PubMed 8209258

  • Woolley SC, Strong MJ. Frontotemporal Dysfunction and Dementia in Amyotrophic Lateral Sclerosis. Neurol Clin. 2015 Nov;33(4):787-805. doi: 10.1016/j.ncl.2015.07.011. Epub 2015 Sep 8.

    PubMed 26515622

  • Walhout R, Verstraete E, van den Heuvel MP, Veldink JH, van den Berg LH. Patterns of symptom development in patients with motor neuron disease. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Feb;19(1-2):21-28. doi: 10.1080/21678421.2017.1386688. Epub 2017 Oct 16.

    PubMed 29037065

  • Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/S1474-4422(17)30115-1. Epub 2017 May 15.

    PubMed 28522181

  • Paganoni S, Macklin EA, Hendrix S, Berry JD, Elliott MA, Maiser S, Karam C, Caress JB, Owegi MA, Quick A, Wymer J, Goutman SA, Heitzman D, Heiman-Patterson T, Jackson CE, Quinn C, Rothstein JD, Kasarskis EJ, Katz J, Jenkins L, Ladha S, Miller TM, Scelsa SN, Vu TH, Fournier CN, Glass JD, Johnson KM, Swenson A, Goyal NA, Pattee GL, Andres PL, Babu S, Chase M, Dagostino D, Dickson SP, Ellison N, Hall M, Hendrix K, Kittle G, McGovern M, Ostrow J, Pothier L, Randall R, Shefner JM, Sherman AV, Tustison E, Vigneswaran P, Walker J, Yu H, Chan J, Wittes J, Cohen J, Klee J, Leslie K, Tanzi RE, Gilbert W, Yeramian PD, Schoenfeld D, Cudkowicz ME. Trial of Sodium Phenylbutyrate-Taurursodiol for Amyotrophic Lateral Sclerosis. N Engl J Med. 2020 Sep 3;383(10):919-930. doi: 10.1056/NEJMoa1916945.

    PubMed 32877582

  • Nikitin D, Makam AN, Suh K, McKenna A, Carlson JJ, Richardson M, Rind DM, Pearson SD. The effectiveness and value of AMX0035 and oral edaravone for amyotrophic lateral sclerosis: A summary from the Institute for Clinical and Economic Review's Midwest Comparative Effectiveness Public Advisory Council. J Manag Care Spec Pharm. 2023 Feb;29(2):216-221. doi: 10.18553/jmcp.2023.29.2.216.

    PubMed 36705279

  • Miller TM, Cudkowicz ME, Genge A, Shaw PJ, Sobue G, Bucelli RC, Chio A, Van Damme P, Ludolph AC, Glass JD, Andrews JA, Babu S, Benatar M, McDermott CJ, Cochrane T, Chary S, Chew S, Zhu H, Wu F, Nestorov I, Graham D, Sun P, McNeill M, Fanning L, Ferguson TA, Fradette S; VALOR and OLE Working Group. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2022 Sep 22;387(12):1099-1110. doi: 10.1056/NEJMoa2204705.

    PubMed 36129998

  • Kiernan MC, Vucic S, Talbot K, McDermott CJ, Hardiman O, Shefner JM, Al-Chalabi A, Huynh W, Cudkowicz M, Talman P, Van den Berg LH, Dharmadasa T, Wicks P, Reilly C, Turner MR. Improving clinical trial outcomes in amyotrophic lateral sclerosis. Nat Rev Neurol. 2021 Feb;17(2):104-118. doi: 10.1038/s41582-020-00434-z. Epub 2020 Dec 18.

    PubMed 33340024

  • Ashhurst JF, Tu S, Timmins HC, Kiernan MC. Progress, development, and challenges in amyotrophic lateral sclerosis clinical trials. Expert Rev Neurother. 2022 Nov-Dec;22(11-12):905-913. doi: 10.1080/14737175.2022.2161893. Epub 2023 Jan 18.

    PubMed 36543326

  • Martinez-Gonzalez L, Martinez A. Emerging clinical investigational drugs for the treatment of amyotrophic lateral sclerosis. Expert Opin Investig Drugs. 2023 Feb;32(2):141-160. doi: 10.1080/13543784.2023.2178416. Epub 2023 Feb 16.

    PubMed 36762798

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis, run by Beth Israel Deaconess Medical Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giulia Cenci (617-667-3056, gcenci@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EIM phase change over time (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06491732, which also lists 51 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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