Early Use of Botulinum Toxin in Spasticity Post Stroke.

Phase 2

Completed

• Conditions: Contracture; Stroke; Muscle Spasticity
• Interventions: Drug: Placebo; Drug: onabotulinumtoxinA

• Registration Number: NCT01882556
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-20
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% NaCl Saline Injection	Placebo	Saline - Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.
Botulinum Toxin - Type A (onabotulinumtoxinA)	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.

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test	6 Months

Secondary Outcome Measures

Name	Time	Method
Strength and Fatigue	6 Months	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.	6 months	Range of movement and force required to produce the same with a custom built device
Spasticity	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

Trial Locations

Locations (1)

Sandwell and West Birmingham NHS Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom