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

Sandwell & West Birmingham Hospitals NHS Trust

Status and phase: Completed; Phase 2

Conditions: Contracture; Stroke; Muscle Spasticity

Treatments: Drug: onabotulinumtoxinA; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01882556

2010-021257-39 (EudraCT Number)

ISRCTN57435427 (Registry Identifier)

PB-PG-0808-16319

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Botulinum Toxin - Type A (onabotulinumtoxinA)

Experimental group

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.

Treatment:

Drug: onabotulinumtoxinA

0.9% NaCl Saline Injection

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo