Clinical trial NCT01751373: Assessment and Management of Post-Stroke Spasticity With Botulinum Toxin-A
Official title: Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in Post-Stroke Spasticity With Botulinum Toxin-A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Muscle Spasticity
Keywords: Botulinum Toxin
Rehabilitation
Electromyography
Electroencephalography
Transcranial Magnetic Stimulation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2012-12-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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 EMG latency and amplitude, 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.


Eligibility 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

Primary outcomes:
measure: Amplitude and timing of electromyographic signals (EMG)
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
Secondary outcomes:
measure: Motor Evoked Potential amplitude
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
measure: Goal Attainment Scale
timeFrame: Baseline, 6 Months
measure: Modified Ashworth Scale
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
measure: Modified Tardieu Scale
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
measure: Frequency and amplitude of electroencephalographic (EEG) activity
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: George Mochizuki, PhD
role: PRINCIPAL_INVESTIGATOR
References: