Re-opening the Critical Period after Stroke (ReCAPS). Version 1.0
Research type
Research Study
Full title
Re-opening the critical period for plasticity after stroke with dose-controlled non-invasive brain stimulation
IRAS ID
248229
Contact name
Jenny Lee
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/08/48, Data protection registration number
Duration of Study in the UK
2 years, 9 months, 18 days
Research summary
Motor impairment of the upper limb after stroke is a major contributor to reduced quality of life (Mansoor et al., 2016), and therefore an important target for treatment. Evidence from animal models and human studies has shown that there is a critical period after stroke in which rapid recovery occurs (Ward, 2017; Prabhakaran et al., 2008) and patients are more responsive to rehabilitative training (Krakauer et al., 2012; Zeiler & Krakauer, 2013; Carmichael, 2006; Zeiler, 2016). This critical period represents an exciting window of opportunity, and understanding it is important for the development of non-invasive brain stimulation therapies.
Animal studies have shown that brain excitability levels are abnormally high during the early post-stroke phase, but then return back to normal levels after 6 months (Krakauer et al., 2012; Zeiler & Krakauer, 2013; Carmichael, 2006). This early excitability is optimal for reorganisation and learning to take place (a process called neuroplasticity), and the aim of this study is to map brain excitability changes in the early and late stages of stroke recovery in humans. It is important that our understanding moves beyond animal models and into the human population, to ensure clinical trials are designed rationally in the future (Ward, 2017; Bernhardt et al., 2017).
Biomarkers are indirect measures of underlying biological events which are difficult to measure directly (Bernhardt et al., 2016). This study will use two biomarkers to measure excitability levels in the brain: Motor evoked potentials (MEPs) (McDonnell & Stinear, 2017), and sensory evoked potentials (SEPs) (Boyd et al., 2017). This study will also use a painless, safe non-invasive brain stimulation (NIBS) technique called transcranial direct current stimulation (tDCS) to alter cortical excitability and to ascertain, for the first time, if it is most effective when applied early or late after stroke, and to optimise protocol by individualising the parameters used.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/1960
Date of REC Opinion
20 Dec 2018
REC opinion
Further Information Favourable Opinion