Can a stimulated muscle biopsy untangle two similar nerve and muscle diseases?

NCT ID NCT07796776

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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.
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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

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Status unknown
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First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

Researchers are testing a muscle biopsy method that uses mild electrical stimulation to sample the junction where nerves meet muscle. The goal is to see if this technique helps distinguish between inclusion body myositis and motor neuron disease, which can look alike. The study involves 30 people with muscle weakness who need a biopsy for diagnosis. Researchers will compare tissue patterns, including a protein called TDP-43, to improve diagnostic accuracy.

What this could mean

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

Active substance
Muscle biopsy with electrostimulation for enhanced neuromuscular junction sampling
What this could lead to
If successful, this approach could sharpen the diagnosis between inclusion body myositis and motor neuron disease, leading to more accurate and earlier treatment decisions.
What could go wrong
This is a small, early diagnostic study with 30 participants, so the technique may not prove reliable in broader populations. The biopsy procedure carries standard risks like bleeding or infection.

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Study facts

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

Participants

About 30 people

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

Started

Jul 2026

Expected to finish

Jul 2030

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

30 adult patients with a neuromuscular disorder (suspected IBM or in differential diagnosis between IBM and MND)

Ages

18 years and older

Sex

Anyone

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: * Patients exhibiting progressive muscle weakness and atrophy with a classic clinical IBM pattern or with an atypical clinical IBM pattern or with an atypical MND pattern * Able to understand and sign the informed consent * Treated according to standard of care clinical practice Exclusion Criteria: * Contraindications to needle EMG or skeletal muscle biopsy * Psychiatric diseases that may interfere with adherence to the follow-up protocol

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • IRCCS Ospedale San Raffaele

    Milan, Italy

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