upper limb spasticity after stroke MedDRA version: 9.1 Level: LLT Classification code 10014498 Term: Embolic stroke MedDRA version: 9.1 Level: LLT Classification code 10019016 Term: Haemorrhagic stroke MedDRA version: 9.1 Level: LLT Classification code 10023027 Term: Ischaemic stroke NOS MedDRA version: 9.1 Level: LLT Classification code 10027580 Term: Middle cerebral artery stroke MedDRA version: 9.1 Level: LLT Classification code 10042244 Term: Stroke MedDRA version: 9.1 Level: LLT Class
Conditions
Interventions
Trade Name: BOTOX
Product Name: not applicable
Product Code: not applicable
Pharmaceutical Form: Powder for solution for injection
CAS Number: 93384-43-1
Other descriptive name: Botulinum toxin type A
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • clinically confirmed diagnosis of stroke; • more than one month post-stroke; • established focal finger or wrist spasticity with an Ashworth score of 2 or more; • spasticity considered clinically to have potential to benefit from treatment with botulinum toxin • the ability to pick up a mug and move it to another position (so that participants are able to use any improvement in hand control in functional reach and grasp tasks); and • agree to comply with recommended contraceptive requirements where appropriate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • contraindications for using botulinum toxin as specified in the manufacturer’s SmPC, that is, individuals with: - a known hypersensitivity to botulinum toxin type A or to any of the excipients - the presence of infection at the proposed injection site(s) • orthopaedic impairments affecting the hemiplegic upper limb or spine (e.g. recent fracture or capsulitis); • clinical evidence of fixed contracture • botulinum toxin to the upper limb within previous 3 months • additional neurological impairment likely to contribute to spasticity (e.g. multiple sclerosis) or interfere with outcome measurements (e.g. visual loss); • uncontrolled shoulder or wrist pain whilst performing the experimental tasks (e.g. due to arthritis); • severe cognitive impairment preventing informed consent and/or the ability to follow task instructions; • the use of aminoglycoside antibiotics or spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. tubocararine-type muscle relaxants) • anti-coagulation with an INR of > 2 or other contraindication to intramuscular injection; and • pregnant or lactating women (or those at risk of pregnancy but not willing to to take adequate precautions to prevent pregnancy during the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether targeted injections of botulinum toxin combined with a standardised physiotherapy intervention improve functional grasp release time in stroke patients more than physiotherapy intervention alone;Secondary Objective: Does the experimental intervention result in an improvement in ability to use the hand for functional activities? We will measure this by (i) using a scale to measure whether the participant achieves a functional goal that he/she set before treatment started, and (ii) standard functional tests for the upper limb (including the Action Research Arm Test and the 9 hole peg test) Can we identify potential predictors (e.g. objective measures of the severity of spasticity, age, or time since stroke) in individuals for active functional improvement in response to botulinum toxin? Does the measurement of muscle spasticity with a standard portable EMG machine (normally used in clinics to guide injection) correlate with a “gold standard” spasticity measurement using a customised motor? Is there evidence that botulinum toxin can selectively decrease muscle spasticity rather than muscle stiffness (measured using the customised motor)?;Primary end point(s): The primary endpoint is the measure of functional grasp release time taken at the immediate outcome assessment (i.e. after injection and up to 4 weeks of physiotherapy) | — |
Countries
United Kingdom
Outcome results
None listed