Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Dr. George Mochizuki, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01751373
First received: December 13, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

Within the first year after stroke, approximately 38% of stroke survivors experience an increased resistance to movement, also called spasticity. One type of treatment that is approved for stroke survivors in Canada that could reduce spasticity is the injection of Botulinum toxin (BTX) into the affected muscle. While BTX reduces spasticity, there is limited evidence to show that BTX administration leads to functional improvements. This may occur because the outcomes aren't sensitive enough to detect change, some people may have better responses to BTX, or because BTX hasn't been paired with the right exercises to improve function. The aims of this research are: i) to determine if there is a way of improving the markers that measure change in response to treatment; and ii) to identify the ideal type of exercise that should be paired with BTX to allow the drug to have it greatest effect.

There are two primary research questions: a) What are the measures that will indicate whether a person with post-stroke spasticity will benefit from BTX therapy? It is hypothesized that electrophysiological measures for those who best respond to BTX will differ from those who demonstrate a weaker response to BTX; b)What is the ideal training approach for improving muscle function in stroke survivors receiving BTX injections? It is hypothesized that a training protocol that focuses on optimizing specific muscle activation patterns will demonstrate better outcomes than a training program designed to improve function.


Condition Intervention
Stroke
Muscle Spasticity
Behavioral: Optimal muscle activation therapy
Behavioral: Standard Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in Post-Stroke Spasticity With Botulinum Toxin-A

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Amplitude and timing of electromyographic signals (EMG) [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 ] [ Designated as safety issue: No ]
    Change in electrical activation patterns of the target muscle(s) (i.e. muscle receiving BTX injection) and the antagonist muscle.


Secondary Outcome Measures:
  • Motor Evoked Potential amplitude [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 ] [ Designated as safety issue: No ]
    To measure the change in cortical excitability associated with the intervention.

  • Goal Attainment Scale [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    Change in Goal Attainment Scale

  • Modified Ashworth Scale [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 ] [ Designated as safety issue: No ]
    Change in Modified Ashworth Scale

  • Modified Tardieu Scale [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 ] [ Designated as safety issue: No ]
    Change in Modified Tardieu Scale

  • Frequency and amplitude of electroencephalographic (EEG) activity [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12 ] [ Designated as safety issue: No ]
    Measurement of event-related cortical activity


Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Therapy
Coupling focal BoNT-A injections with a therapy program comprising of functional tasks.
Behavioral: Standard Therapy
Experimental: Optimal Muscle Activation Therapy
Coupling focal BoNT-A injections with a motor training program that focuses on developing and maintaining activation patterns in the muscle treated with BoNT-A.
Behavioral: Optimal muscle activation therapy
The proposed study uses a longitudinal, within-subject, pre/post intervention, cross-over design. All participants will complete each of 4 study phases (each 12 weeks long). These include: a) focal BTX injections in combination with either Standard Therapy or Optimal Muscle Activity Therapy; b) a three-month period where no treatment is given; c) focal BTX injections in combination either Standard Therapy or Optimal Muscle Activation Therapy; d) another three-month period where no treatment is given. The order of treatment phases will be counter-balanced across participants.
Other Names:
  • Botulinum Toxin-A
  • Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >120 days post first ischemic stroke
  • Unilateral spasticity (MAS ≥ 1) of the wrist or elbow
  • >18 years of age
  • Medical referral for focal BoNT-A injections
  • Residual active control of the wrist or elbow

Exclusion Criteria:

  • Underlying neuromuscular disorders (i.e. ALS, neuropathies, myasthenia gravis)
  • Inability to provide informed consent or communicate in English
  • Bilateral paresis/spasticity
  • Contractures
  • Prescribed anti-spastic medication
  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: NCT01751373

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Allergan
Investigators
Principal Investigator: George Mochizuki, PhD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. George Mochizuki, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01751373     History of Changes
Other Study ID Numbers: ALSRIIIT-01
Study First Received: December 13, 2012
Last Updated: February 6, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Botulinum Toxin
Rehabilitation
Electromyography
Electroencephalography
Transcranial Magnetic Stimulation

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

ClinicalTrials.gov processed this record on October 01, 2014