Upper-limb Active Function and Botulinum Toxin A
Key facts
- Where
- St Amand Les Eaux és Toulouse, FranciaországSee the 2 sites
- Phase
- 2. fázis
Where in Franciaország
- Centre Hospitalier De St Amand Les EauxSt Amand Les Eaux, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de ToulouseToulouse, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire De Toulouse
- Trial code
- EU 2024-518147-37-00
- Record updated
- 2024. október 31.
- Original description
Evaluer l’effet d’injections de toxine botulique A dans les fléchisseurs du coude sur la réduction des cocontractions spastiques au cours d’un mouvement d’extension active de coude chez des patients hémiplégiques vasculaires chroniques.Read full original descriptionShow less
Evaluer l’effet d’injections de toxine botulique A dans les fléchisseurs du coude sur la réduction des cocontractions spastiques au cours d’un mouvement d’extension active de coude chez des patients hémiplégiques vasculaires chroniques.
Inclusion: Patient group: Ischemic or hemorrhagic stroke of more than 6 months, of cortical and/or subcortical location; Control group: Age > 18 years; Control group: Signing of informed consent; 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; Patient group: Being prescribed the molecule abobotulinumtoxinA (DYSPORT®, Ipsen-Pharma); Patient group: Possibility of active elbow extension of at least 20°; Patient group: Limitation of active elbow extension movement by at least 15° or performance of a complete movement with a speed reduced by 50%; Patient group: TBA-naïve patients or more than 4 months after a first TBA injection, targeting the elbow flexors; Patient group: Age > 18 years; Patient group: Signing of informed consent; Patient group: Patient affiliated to a social security scheme.
Exclusion: Patient group: Cognitive disorder limiting the understanding of three basic instructions (test type of the 3 MMS papers test); Patient group: Unstable epilepsy; Patient group: Anticoagulant treatment at curative dose or haemostasis disorder (prolonged bleeding time) contraindicating intramuscular injections; 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; Patient group: Passive limitation of elbow extension > 30°; Patient group: Legal incapacity (judicial protection, curatorship, guardianship); Patient group: Pregnant or breastfeeding women; Patient group: Women who want to become pregnant within 18 months; 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; Control group: History or progressive orthopedic or neurological damage to the upper limbs; Control group: Subject expert in a sport requiring intensive use of the upper limbs (competition, at least departmental level); Control group: Legal incapacity (judicial protection, curatorship, guardianship); Patient group: Pain when performing active elbow flexion/extension movements; Patient group: Boston Diagnostic Severity Aphasia Examination score ≤3; Patient group: Progressive or decompensated neurological pathology; Patient group: Claustrophobia or metallic foreign bodies contraindicating the performance of an MRI.