Botulinum toxin type A - haemagglutinin complex (abobotulinumtoxinA) for Ischemic stroke | Haemorrhagic stroke

Inclusion criteria

• {"criterion_text":"- Patient group: Ischemic or hemorrhagic stroke of more than 6 months, of cortical and/or subcortical location\n- Control group: Age > 18 years\n- Control group: Signing of informed consent.\n- Patient group: Indication for performing a TBA injection in the elbow flexor muscles according to the usual clinical criteria: presence of a functional or aesthetic complaint expressed by the patient, linked to muscular hyperactivity (spasticity or co-contraction) on the elbow flexor muscles, and requiring focal treatment by injection of botulinum toxin\n- Patient group: Being prescribed the molecule abobotulinumtoxinA (DYSPORT®, Ipsen-Pharma)\n- Patient group: Possibility of active elbow extension of at least 20°\n- Patient group: Limitation of active elbow extension movement by at least 15° or performance of a complete movement with a speed reduced by 50%\n- Patient group: TBA-naïve patients or more than 4 months after a first TBA injection, targeting the elbow flexors\n- Patient group: Age > 18 years\n- Patient group: Signing of informed consent\n- Patient group: Patient affiliated to a social security scheme."}

Exclusion criteria

• {"criterion_text":"- Patient group: Passive limitation of elbow extension > 30°\n- Patient group: Legal incapacity (judicial protection, curatorship, guardianship)\n- Patient group: Pregnant or breastfeeding women\n- Patient group: Women who want to become pregnant within 18 months\n- Patient group: Premenopausal women (menopause being defined by an absence of menstruation for at least 12 months without medical intervention) not using one of the following methods of contraception considered to be very reliable: intrauterine device, estrogen-progestin or progestin contraception inhibiting ovulation delivered by an implanted subcutaneous device, or tubal ligation.\n- Control group: History or progressive orthopedic or neurological damage to the upper limbs\n- Control group: Subject expert in a sport requiring intensive use of the upper limbs (competition, at least departmental level)\n- Control group: Legal incapacity (judicial protection, curatorship, guardianship).\n- Patient group: Pain when performing active elbow flexion/extension movements\n- Patient group: Cognitive disorder limiting the understanding of three basic instructions (test type of the 3 MMS papers test)\n- Patient group: Boston Diagnostic Severity Aphasia Examination score ≤3\n- Patient group: Progressive or decompensated neurological pathology\n- Patient group: Unstable epilepsy\n- Patient group: General contraindication to the use of botulinum toxin: hypersensitivity to the active substance (toxin-haemagglutinin complex BoTX-A) or to one of the excipients (albumin solution), history of myasthenia, Lambert Eaton syndrome, history of neuromuscular disease, surgery with curarization for less than 1 month, treatment with aminoglycosides, aminoquinolines, cyclosporine or anticholinesterases, History or presence of swallowing disorders (choking on solids or liquids), History or presence of chronic respiratory disorders (known respiratory failure), presence of a skin infection or inflammation at the injection site\n- Patient group: Anticoagulant treatment at curative dose or haemostasis disorder (prolonged bleeding time) contraindicating intramuscular injections\n- Patient group: Claustrophobia or metallic foreign bodies contraindicating the performance of an MRI"}

Primary endpoints

• {"endpoint_text":"- Measurement of the spastic cocontraction index (ICCS) during active elbow extension movement, obtained from the EMG signal of the elbow extensor and flexor muscles on the paretic side, between T1 and T2 (before versus 4 weeks after TBA injection)","definition_or_measurement_approach":"ICCS measured from the EMG signal of elbow extensor and flexor muscles on the paretic side; comparison between T1 (before injection) and T2 (4 weeks after TBA injection)."}

Secondary endpoints

• {"endpoint_text":"- Spasticity of the elbow flexors according to Tardieu\n- Limitation of the active movement angle (LAMA) of elbow extension\n- Fugl-Meyer score (motor selectivity)\n- Functional abilities with the Wolf Motor Function Test (WMFT) score\n- EEG quantification of bilateral cortical activity during movement (real or imagined) to calculate the following indices: o desynchronization index (ERD) identifying hyperactivity in the ipsilesional cortex; o synchronization index quotient (ERS) to assess interhemispheric inhibition (inhibition laterality coefficient) o amount of interhemispheric coherence\n- Corticospinal excitability (curve of variation of MEP amplitude as a function of stimulation intensity) assessed by TMS\n- Anatomical lesions of the motor pathways (motor cortex and descending motor pathways) obtained from anatomical (T1) and diffusion-weighted MRI","definition_or_measurement_approach":"Spasticity assessed by Tardieu scale; LAMA = measurement of active elbow extension angle limitation; Fugl-Meyer used for motor selectivity scoring; WMFT for functional ability scoring; EEG used to quantify ERD, ERS and interhemispheric coherence during real or imagined movement; TMS to assess corticospinal excitability by MEP amplitude vs stimulation intensity curve; MRI (T1 and diffusion) to characterise anatomical lesions of motor pathways."}

France

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

31-10-2024

Processing Time Days

14

Number Of Sites

2

Number Of Participants

80

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France