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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Sandwell & West Birmingham Hospitals NHS Trust
Sponsor:
Collaborators:
Keele University
Stroke Research Network
Information provided by (Responsible Party):
Cameron Lindsay, Sandwell & West Birmingham Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01882556
First received: June 18, 2013
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Stroke
Muscle Spasticity
Contracture
Drug: onabotulinumtoxinA
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sandwell & West Birmingham Hospitals NHS Trust:

Primary Outcome Measures:
  • Action Research Arm Test [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spasticity [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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

  • Strength and Fatigue [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Range of movement and force required to produce the same with a custom built device


Other Outcome Measures:
  • Quality of Life [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    EuroQol EQ-5D

  • Care Giver Strain Index [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: onabotulinumtoxinA
Other Names:
  • Botox
  • Botulinum toxin type-A
Placebo Comparator: 0.9% NaCl Saline Injection
Saline - Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882556

Contacts
Contact: Cameron Lindsay, BSc, PGDip +44121 507 4486 camlin3@hotmail.com

Locations
United Kingdom
Sandwell and West Birmingham NHS Trust Recruiting
Birmingham, West Midlands, United Kingdom, B18 7QH
Contact: Cameron Lindsay, BSc, PGDip    121 507 4486    camlin3@hotmail.com   
Principal Investigator: Sissi Ispoglou, MBChB         
Sponsors and Collaborators
Sandwell & West Birmingham Hospitals NHS Trust
Keele University
Stroke Research Network
Investigators
Study Chair: Anand D Pandyan, PhD Keele University
Principal Investigator: Stephen G Sturman, MB ChB SWBH NHS Trust
  More Information

No publications provided by Sandwell & West Birmingham Hospitals NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cameron Lindsay, Mr, Sandwell & West Birmingham Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01882556     History of Changes
Other Study ID Numbers: PB-PG-0808-16319, 2010-021257-39, ISRCTN57435427
Study First Received: June 18, 2013
Last Updated: June 19, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sandwell & West Birmingham Hospitals NHS Trust:
Early treatment of spasticity.
Post stroke spasticity.

Additional relevant MeSH terms:
Muscle Spasticity
Cerebral Infarction
Contracture
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Joint Diseases
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Vascular Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014