Early Use of Botulinum Toxin in Spasticity Post Stroke.

NCT ID: NCT01882556

Last Updated: 2014-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-05-31

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.

Conditions

Stroke; Muscle Spasticity; Contracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

onabotulinumtoxinA

Intervention Type: DRUG

0.9% NaCl Saline Injection

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

onabotulinumtoxinA

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Botox; Botulinum toxin type-A

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keele University

OTHER

Sponsor Role: collaborator

Stroke Research Network

UNKNOWN

Sponsor Role: collaborator

Sandwell & West Birmingham Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Cameron Lindsay

Mr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anand D Pandyan, PhD

Role: STUDY_CHAIR

Keele University

Stephen G Sturman, MB ChB

Role: PRINCIPAL_INVESTIGATOR

SWBH NHS Trust

Locations

Sandwell and West Birmingham NHS Trust

Birmingham, West Midlands, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 24401159 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36325678 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33040610 (View on PubMed)

Other Identifiers

2010-021257-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISRCTN57435427

Identifier Type: REGISTRY

Identifier Source: secondary_id

PB-PG-0808-16319

Identifier Type: -

Identifier Source: org_study_id