Early Use of Botulinum Toxin in Spasticity Post Stroke.

Stroke Clinical Trial

— EUBoSS  

Official 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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882556
• Other study ID #: PB-PG-0808-16319
• Secondary ID: 2010-021257-39IS
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2013
• Last updated: November 17, 2014
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Sandwell & West Birmingham Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contracture
• Muscle Spasticity
• Stroke

Intervention

Drug:
• onabotulinumtoxinA

• Placebo

Locations

Country	Name	City	State
United Kingdom	Sandwell and West Birmingham NHS Trust	Birmingham	West Midlands

Sponsors (3)

Lead Sponsor	Collaborator
Sandwell & West Birmingham Hospitals NHS Trust	Keele University, Stroke Research Network

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life	EuroQol EQ-5D	6 Months	No
Other	Care Giver Strain Index		6 Months	No
Primary	Action Research Arm Test		6 Months	No
Secondary	Spasticity	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	6 Months	No
Secondary	Strength and Fatigue	Strength and fatigue as measured by maximum isometric strength and the rate of force production in the wrist and elbow joints	6 Months	No
Secondary	Stiffness and passive range of movement.	Range of movement and force required to produce the same with a custom built device	6 months	No