Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A
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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 |
- 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.
- 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:
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: George Mochizuki, PhD | 416-480-6100 ext 83737 | george.mochizuki@sunnybrook.ca |
| Contact: Haseel Bhatt, MSc | 416-480-6100 ext 85402 | haseel.bhatt@sunnybrook.ca |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| 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: | December 13, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Botulinum Toxin Rehabilitation Electromyography Electroencephalography Transcranial Magnetic Stimulation |
Additional relevant MeSH terms:
|
Muscle Spasticity Stroke Cerebral Infarction Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013