Early Use of Botulinum Toxin in Spasticity Post Stroke.

NCT01882556 | Completed Phase 2

• 3 other identifiers: PB-PG-0808-163192010-021257-39ISRCTN57435427
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Early treatment of spasticity.; Post stroke spasticity.

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test

  6 Months

Secondary Outcomes (3)

• Spasticity

  6 Months

• Strength and Fatigue

  6 Months

• Stiffness and passive range of movement.

  6 months

Other Outcomes (2)

• Quality of Life

  6 Months

• Care Giver Strain Index

  6 Months

Study Arms (2)

Botulinum Toxin - Type A (onabotulinumtoxinA)

EXPERIMENTAL

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

0.9% NaCl Saline Injection

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

onabotulinumtoxinA DRUG

Also known as: Botox, Botulinum toxin type-A

Botulinum Toxin - Type A (onabotulinumtoxinA)

Placebo DRUG

0.9% NaCl Saline Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead
• Keele University: collaborator
• Stroke Research Network: collaborator

Study Sites (1)

Sandwell and West Birmingham NHS Trust

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 24401159 BACKGROUND

• 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.

  PMID: 36325678 DERIVED

• 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.

  PMID: 33040610 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Contracture

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Anand D Pandyan, PhD

  Keele University

  STUDY CHAIR

• Stephen G Sturman, MB ChB

  SWBH NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 20, 2013
• Study Start: January 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

GB (1)