BridgeMD
Upper-limb Active Function and Botulinum Toxin A
EU CTIS ID: 2024-518147-37-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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°
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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: Cognitive disorder limiting the understanding of three basic instructions (test type of the 3 MMS papers test)
- Patient group: Boston Diagnostic Severity Aphasia Examination score ≤3
- Patient group: Progressive or decompensated neurological pathology
- Patient group: Unstable epilepsy
- 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: Anticoagulant treatment at curative dose or haemostasis disorder (prolonged bleeding time) contraindicating intramuscular injections
- Patient group: Claustrophobia or metallic foreign bodies contraindicating the performance of an MRI
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.