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Completed

NCT Number: NCT01882556

Early Use of Botulinum Toxin in Spasticity Post Stroke.

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Contracture Joint Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sandwell and West Birmingham NHS Trust

Birmingham, West Midlands, B18 7QH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OnabotulinumtoxinA

Drug

Other names: Botox, Botulinum toxin type-A

Placebo

Drug

Primary outcomes

  1. Action Research Arm Test

    Time frame: 6 Months

Secondary outcomes

  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 outcomes

  1. Quality of Life

    Time frame: 6 Months

    EuroQol EQ-5D

  2. Care Giver Strain Index

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Sandwell & West Birmingham Hospitals NHS Trust

Other

Collaborators

  • Keele University
  • Stroke Research Network

Registry information

Official study 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?

Acronym: EUBoSS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2013
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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