COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01882556
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : November 18, 2014
Keele University
Stroke Research Network
Information provided by (Responsible Party):
Cameron Lindsay, Sandwell & West Birmingham Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Stroke Muscle Spasticity Contracture Drug: onabotulinumtoxinA Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Botulinum Toxin - Type A (onabotulinumtoxinA)
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.
Drug: onabotulinumtoxinA
Other Names:
  • Botox
  • Botulinum toxin type-A

Placebo Comparator: 0.9% NaCl Saline Injection
Saline - Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.
Drug: Placebo

Primary Outcome Measures :
  1. Action Research Arm Test [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Spasticity [ Time Frame: 6 Months ]
    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

  2. Strength and Fatigue [ Time Frame: 6 Months ]
    Strength and fatigue as measured by maximum isometric strength and the rate of force production in the wrist and elbow joints

  3. Stiffness and passive range of movement. [ Time Frame: 6 months ]
    Range of movement and force required to produce the same with a custom built device

Other Outcome Measures:
  1. Quality of Life [ Time Frame: 6 Months ]
    EuroQol EQ-5D

  2. Care Giver Strain Index [ Time Frame: 6 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01882556

Layout table for location information
United Kingdom
Sandwell and West Birmingham NHS Trust
Birmingham, West Midlands, United Kingdom, B18 7QH
Sponsors and Collaborators
Sandwell & West Birmingham Hospitals NHS Trust
Keele University
Stroke Research Network
Layout table for investigator information
Study Chair: Anand D Pandyan, PhD Keele University
Principal Investigator: Stephen G Sturman, MB ChB SWBH NHS Trust
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cameron Lindsay, Mr, Sandwell & West Birmingham Hospitals NHS Trust Identifier: NCT01882556    
Other Study ID Numbers: PB-PG-0808-16319
2010-021257-39 ( EudraCT Number )
ISRCTN57435427 ( Registry Identifier: ISRCTN )
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014
Keywords provided by Cameron Lindsay, Sandwell & West Birmingham Hospitals NHS Trust:
Early treatment of spasticity.
Post stroke spasticity.
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Joint Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents