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Painless muscle test could speed up ALS diagnosis

NCT ID NCT05104710

Diagnosis Sponsor: University of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a quick, painless measurement of muscle activity using surface electrodes can help doctors diagnose ALS earlier and more accurately. Researchers will compare this test to current methods in 650 people with muscle symptoms. They will also track how the test changes over time in ALS patients to see if it matches disease progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a faster, more accurate way to diagnose ALS, helping patients get care sooner.
What could go wrong
This is an observational study, not a treatment trial. The test may not prove reliable enough for widespread use, and results may take years to confirm.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 650 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

AIM 1: The study population includes patients with symptomatology suggestive of ALS who are referred to neuromuscular clinics at one of the four participating centers. AIM 2: All healthy subjects between 20 and 90 years old. AIM 3: Patients with suspected ALS who had an initially detectible IMC-βγ.

Ages

20 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * AIM 1: Patients with arm or leg weakness, spastic gait, muscle wasting and/or fasciculations (muscle twitching), dysphagia (difficulty swallowing), dysarthria (difficulty speaking), shortness of breath, hyperreflexia or pathological reflexes, or findings of muscle denervation in previous needle electromyography (EMG) studies. * AIM 2: Subjects between 20 and 90 years of age. * AIM 3: Subjects will be selected from among Aim 1 patients who carry an Awaji (without IMC) category of Possible, Probable, or Definite ALS. Exclusion Criteria: * AIM 1: 1. Classified as probable or definite ALS by Awaji criteria prior to initial study evaluation 2. Have significant sensory loss in the weak or spastic limbs 3. Have significant musculoskeletal or neuropathic pain 4. Have an inability or are unwilling to provide informed consent 5. Are unable to perform the study-related task 6. Are taking baclofen or benzodiazepines 7. Have a known non-ALS cause for symptoms * AIM 2: 1. Have a history of neurological disorders such as stroke, neuropathy, or myopathy 2. Have significant pain or sensory loss 3. Are taking baclofen or sedatives such as benzodiazepines 4. Lack of cognitive ability or willingness to provide informed consent * AIM 3: 1. Were unclassified according to the Awaji category or had a defined ALS mimic 2. Are taking baclofen, sedatives or benzodiazepines. NOTE: Participation in a therapeutic clinical trial is NOT an exclusion criterion since this study would not interfere with any potential interventions.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • University of California Center for Clinical Research

    ACTIVE_NOT_RECRUITING

    Irvine, California, 92697, United States

  • University of Miami Miller School of Medicine

    RECRUITING

    Miami, Florida, 33136, United States

  • Washington University Medical Center

    RECRUITING

    St Louis, Missouri, 63110, United States

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