Can a stimulated muscle biopsy untangle two similar nerve and muscle diseases?
NCT ID NCT07796776
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
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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
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Anyone
Show the full entry requirements Hide 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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