Variability of the Unique Fiber Potentials of a Spastic Muscle Treated With Botulinum Toxin (JITTOX)
Stroke Patient
About this trial
This is an interventional other trial for Stroke Patient focused on measuring jitter, single fiber EMG, botulinum toxin
Eligibility Criteria
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
Sites / Locations
- CHU de NîmesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Other
- Virgin patients with Botulinum Toxin, first injection
- Injected group: Patients already injected
Control
Experimental: - Virgin patients with Botulinum Toxin, first injection A clinical evaluation of spasticity with the Modified Ashworth Scale by the referent practitioner. Pain management: according to the patient's wishes, local anaesthetic can be provided on the target area (EMLA patch type) Single fiber electrophysiological evaluation by the principal investigator: comfortable installation of the patient in decubitus, with the upper limb in the optimal relaxation position, supported by the examiner to achieve minimal tone. Arrangement of the needle electrode at the level of the elbow flexor muscle chosen (biceps brachialis, anterior brachialis), located ultrasonographically. Repeated measurements at D0, week 4 to 6 and week 12 for the stroke patients. Only one measure for controls subjects
- Injected group: Patients already injected A clinical evaluation of spasticity with the Modified Ashworth Scale by the referent practitioner. Pain management: according to the patient's wishes, local anaesthetic can be provided on the target area (EMLA patch type) Single fiber electrophysiological evaluation by the principal investigator: comfortable installation of the patient in decubitus, with the upper limb in the optimal relaxation position, supported by the examiner to achieve minimal tone. Arrangement of the needle electrode at the level of in one elbow flexor muscle (biceps brachialis, anterior brachialis), located ultrasonographically. Repeated measurements at D0, week 4 to 6 and week 12 for the stroke patients. Only one measure for controls subjects
healthy patient matched in age and sex to included patients