search
Back to results

Early Use of Botulinum Toxin in Spasticity Post Stroke. (EUBoSS)

Primary Purpose

Stroke, Muscle Spasticity, Contracture

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
onabotulinumtoxinA
Placebo
Sponsored by
Sandwell & West Birmingham Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Early treatment of spasticity., Post stroke spasticity.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Over 18 years of age.
  2. 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
  3. Capable of providing informed consent directly or indirectly, or, consent obtainable from next of kin or legal representative
  4. 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 Criteria:

  1. Significant musculoskeletal conditions that affected upper limb function prior to the stroke
  2. Unconscious or moribund during the screening period
  3. Recovery of useful arm function (a score of 3 or more in the grasp section of the Action Research Arm Test) prior to injections
  4. 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)
  5. Previous upper motor neurone syndrome or hypertonicity due to multiple sclerosis, spinal cord injury or other neurological disorder
  6. Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin)
  7. Patients with myasthenia gravis or Eaton Lambert Syndrome or other neuromuscular junction or myopathic disorder
  8. Patients with infection at the proposed injection site(s)
  9. Patients who are pregnant or may become pregnant at the time of the proposed injections and for the duration of the study
  10. Current treatment with any antispasticity agent or previous injection with BOTOX

Sites / Locations

  • Sandwell and West Birmingham NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum Toxin - Type A (onabotulinumtoxinA)

0.9% NaCl Saline Injection

Arm Description

Botulinum Toxin - Type A. One set of injections of up to 200 Units of Botox (Allergan). Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.

Saline - Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.

Outcomes

Primary Outcome Measures

Action Research Arm Test

Secondary Outcome Measures

Spasticity
In reducing focal spasticity in the arm as measured by surface electromyography (EMG) response of the wrist and elbow flexors to an externally imposed perturbation
Strength and Fatigue
Strength and fatigue as measured by maximum isometric strength and the rate of force production in the wrist and elbow joints
Stiffness and passive range of movement.
Range of movement and force required to produce the same with a custom built device

Full Information

First Posted
June 18, 2013
Last Updated
November 17, 2014
Sponsor
Sandwell & West Birmingham Hospitals NHS Trust
Collaborators
Keele University, Stroke Research Network
search

1. Study Identification

Unique Protocol Identification Number
NCT01882556
Brief Title
Early Use of Botulinum Toxin in Spasticity Post Stroke.
Acronym
EUBoSS
Official Title
Is it Clinically Effective to Treat Arm Flexor Spasticity, With Botulinum Toxin - Type A (BoNTA) and Physiotherapy, as Soon as Signs of Abnormal Muscle Activity Are Observed?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sandwell & West Birmingham Hospitals NHS Trust
Collaborators
Keele University, Stroke Research Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 unwanted muscle overactivity, if left untreated or poorly managed, can lead to limb deformities. For example, the wrist and fingers in the arm affected by spasticity become stiff and curl into a fist and the hand cannot be used for any functional purpose. Palm hygiene can become difficult and patients find this deformity unsightly and painful. Botulinum toxin (BT) has been shown to reduce muscle overactivity and is licensed for this purpose. In current practice this treatment is often used as a last line of defence. Although BT can reduce the muscle overactivity, when injected using current protocols, it seems to have little impact on the recovery of function and/or treating the limb deformities and pain. If BT can be given in the early stages of a stroke, i.e. as soon as the muscle overactivity is observed, then we will be able to treat spasticity and may prevent the limb deformities and pain from developing. We may also be able to assist the recovery of arm movement in some of the patients who would otherwise not have regained this. In addition to benefiting the patient, the prevention of secondary complications by early treatment may reduce the costs of long term care to the NHS . We hope to discover if our plan of providing early treatment with BT is more effective than the current approach. If we demonstrate that the treatment is effective we will be able to introduce this new method almost immediately within the NHS through our collaboration with doctors and therapists who are actively treating patients with this condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Muscle Spasticity, Contracture
Keywords
Early treatment of spasticity., Post stroke spasticity.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum Toxin - Type A (onabotulinumtoxinA)
Arm Type
Experimental
Arm Description
Botulinum Toxin - Type A. One set of injections of up to 200 Units of Botox (Allergan). Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.
Arm Title
0.9% NaCl Saline Injection
Arm Type
Placebo Comparator
Arm Description
Saline - Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.
Intervention Type
Drug
Intervention Name(s)
onabotulinumtoxinA
Other Intervention Name(s)
Botox, Botulinum toxin type-A
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Action Research Arm Test
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Spasticity
Description
In reducing focal spasticity in the arm as measured by surface electromyography (EMG) response of the wrist and elbow flexors to an externally imposed perturbation
Time Frame
6 Months
Title
Strength and Fatigue
Description
Strength and fatigue as measured by maximum isometric strength and the rate of force production in the wrist and elbow joints
Time Frame
6 Months
Title
Stiffness and passive range of movement.
Description
Range of movement and force required to produce the same with a custom built device
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
EuroQol EQ-5D
Time Frame
6 Months
Title
Care Giver Strain Index
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand D Pandyan, PhD
Organizational Affiliation
Keele University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephen G Sturman, MB ChB
Organizational Affiliation
SWBH NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandwell and West Birmingham NHS Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B18 7QH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24401159
Citation
Lindsay C, Simpson J, Ispoglou S, Sturman SG, Pandyan AD. The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial. Trials. 2014 Jan 8;15:12. doi: 10.1186/1745-6215-15-12.
Results Reference
background
PubMed Identifier
36325678
Citation
Lindsay C, Humphreys I, Phillips C, Pandyan A. Estimating the cost consequence of the early use of botulinum toxin in post-stroke spasticity: Secondary analysis of a randomised controlled trial. Clin Rehabil. 2023 Mar;37(3):373-380. doi: 10.1177/02692155221133522. Epub 2022 Nov 3.
Results Reference
derived
PubMed Identifier
33040610
Citation
Lindsay C, Ispoglou S, Helliwell B, Hicklin D, Sturman S, Pandyan A. Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial. Clin Rehabil. 2021 Mar;35(3):399-409. doi: 10.1177/0269215520963855. Epub 2020 Oct 11.
Results Reference
derived

Learn more about this trial

Early Use of Botulinum Toxin in Spasticity Post Stroke.

We'll reach out to this number within 24 hrs