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

Stroke Clinical Trial

Official title:

Novel Assessment and Treatment Approaches for Detecting and Facilitating Functional Improvements in Post-Stroke Spasticity With Botulinum Toxin-A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751373
• Other study ID #: ALSRIIIT-01
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: May 19, 2015
• Start date: May 2011
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

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.
• Standard Therapy

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude and timing of electromyographic signals (EMG)	Change in electrical activation patterns of the target muscle(s) (i.e. muscle receiving BTX injection) and the antagonist muscle.	Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12	No
Secondary	Motor Evoked Potential amplitude	To measure the change in cortical excitability associated with the intervention.	Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12	No
Secondary	Goal Attainment Scale	Change in Goal Attainment Scale	Baseline, 6 Months	No
Secondary	Modified Ashworth Scale	Change in Modified Ashworth Scale	Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12	No
Secondary	Modified Tardieu Scale	Change in Modified Tardieu Scale	Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12	No
Secondary	Frequency and amplitude of electroencephalographic (EEG) activity	Measurement of event-related cortical activity	Baseline, Month 1, Month 2, Month 3, Month 6, Month 7, Month 8, Month 9, Month 12	No