Tiny muscle signals could predict botox success in stroke survivors
NCT ID NCT04002843
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 40 stroke patients with arm muscle stiffness (spasticity) who were treated with botulinum toxin (Botox). Researchers measured tiny electrical signals in the muscle to see how they change over time and whether they relate to how well the treatment works. The goal was to better understand how Botox affects nerve-muscle communication and possibly find a way to predict when the effect starts to wear off.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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40 people
The number who actually took part.
- Started
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Aug 2019
- Finished
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Nov 2023
- Lead sponsor
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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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
Stroke Patients : Inclusion Criteria: * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient is available for a follow-up of up to six months * Women and men are included * The patient is at least 18 years old * Subjects with upper limb spasticity involving the biceps brachial muscle, with a modified Ashworth score greater than or equal to 1, after hemorrhagic and/or ischemic stroke. * Patients will be voluntarily selected at three months of stroke to minimize the variability in single-fiber parameters caused by the central event itself Exclusion Criteria: * The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * The patient is pregnant or breastfeeding * The subject is minor * The subject is under guardianship or curatorship * History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs * The subject has fixed retractions or bone deformities to the affected upper limb * Other upper limb disorders (bilateral stroke, peripheral neuropathy, peripheral nerve injury (s), nerve compression syndrome, myopathy, severe osteoarthritis, recent muscle injury (s), recent bone, fracture, joint replacement) * Subjects with an intrathecal baclofen pump * Subjects with general anaesthesia scheduled within three months of treatment * Ongoing conditions contraindicating BTA treatment (especially respiratory disease) * Psychiatric disorders (other than anxiety disorder) Stroke Patients : Inclusion Criteria: * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient is available for a follow-up of up to six months * Women and men are included * The patient is at least 18 years old * Subjects with upper limb spasticity involving one of elbow flexor muscle, with a modified Ashworth score greater than or equal to 1, after hemorrhagic and/or ischemic stroke. * Patients will be voluntarily selected at three months of stroke to minimize the variability in single-fiber parameters caused by the central event itself Exclusion Criteria: * The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * The patient is pregnant or breastfeeding * The subject is minor * The subject is under guardianship or curatorship * History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs * The subject has fixed retractions or bone deformities to the affected upper limb * Other upper limb disorders (bilateral stroke, peripheral neuropathy, peripheral nerve injury (s), nerve compression syndrome, myopathy, severe osteoarthritis, recent muscle injury (s), recent bone, fracture, joint replacement) * Subjects with an intrathecal baclofen pump * Subjects with general anaesthesia scheduled within three months of treatment * Ongoing conditions contraindicating BTA treatment (especially respiratory disease) * Psychiatric disorders (other than anxiety disorder) * The subject will be excluded if abnormalities will be found on prior EMG Control Subjects : Inclusion Criteria: * The subject must have given their free and informed consent and signed the consent form * The subject must be a member or beneficiary of a health insurance plan * The subject should only be available on the day of recording * Women and men are included * The patient is at least 18 years old * They will be matched to stroke patient by age (+/- 5 years) and sex Exclusion Criteria : * The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * The patient is pregnant or breastfeeding * The subject is minor * The subject is under guardianship or curatorship * History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs * The subject has limb disorders (peripheral neuropathy, peripheral nerve injury (s), nerve compression syndrome, myopathy) * The subject will be excluded if abnormalities will be found on prior EMG
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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
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CHU de Nîmes
Nîmes, 30009, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.