Status:
COMPLETED
Early Use of Botulinum Toxin in Spasticity Post Stroke.
Lead Sponsor:
Sandwell & West Birmingham Hospitals NHS Trust
Collaborating Sponsors:
Keele University
Stroke Research Network
Conditions:
Stroke
Muscle Spasticity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients who survive a stroke are often left with an arm that cannot be used. One reason for this is that the muscles affected by the stroke become overactive. This is known as spasticity. Such unwant...
Eligibility Criteria
Inclusion
- Over 18 years of age.
- Patients with stroke due to a primary cerebral haemorrhage/infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemiplegia
- Capable of providing informed consent directly or indirectly, or, consent obtainable from next of kin or legal representative
- No useful arm function (i.e. less than or equal to 2 on the grasp subsection of the Action Research Arm Test) at onset of spasticity
Exclusion
- Significant musculoskeletal conditions that affected upper limb function prior to the stroke
- Unconscious or moribund during the screening period
- Recovery of useful arm function (a score of 3 or more in the grasp section of the Action Research Arm Test) prior to injections
- Patients with contraindications to electrical stimulation including active implants (e.g. cardiac assist devices), metal implants at site of stimulation, scar tissue/cancerous tissue at site of stimulation, uncontrolled epilepsy, deep vein thrombosis in limb / muscle being stimulated and pregnancy (or planned pregnancy)
- Previous upper motor neurone syndrome or hypertonicity due to multiple sclerosis, spinal cord injury or other neurological disorder
- Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin)
- Patients with myasthenia gravis or Eaton Lambert Syndrome or other neuromuscular junction or myopathic disorder
- Patients with infection at the proposed injection site(s)
- Patients who are pregnant or may become pregnant at the time of the proposed injections and for the duration of the study
- Current treatment with any antispasticity agent or previous injection with BOTOX
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01882556
Start Date
January 1 2012
End Date
May 1 2014
Last Update
November 18 2014
Active Locations (1)
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1
Sandwell and West Birmingham NHS Trust
Birmingham, West Midlands, United Kingdom, B18 7QH