Previous studies suggest that a drug used to treat depression, called ‘fluoxetine’, may also be used to improve physical rehabilitation after stroke. It is thought that fluoxetine could work by increasing ‘plasticity’ in the brain, which is its ability to form new connections between brain cells.
In response, the Stroke Association is already funding a large, multicentre study to more reliably determine the effectiveness of fluoxetine against a ‘dummy’ drug (placebo). The study is called FOCUS (Fluoxetine Or Control Under Supervision).
However, FOCUS is not investigating how fluoxetine might actually work. That is why we are now funding this current ‘add on’ study. It will test FOCUS patients with a non-invasive, safe type of brain stimulation called rTMS (repeated transcranial magnetic stimulation).
The rTMS will be given to the patients across three sessions. First in the early days after stroke, just before a patient has received fluoxetine (or the dummy-drug), then at 6 weeks and 6 months later once they are taking fluoxetine daily. At each session, the researchers will record patients’ muscle activity responses to the rTMS brain stimulation. They will also perform a physical examination. This will build a picture of the changes in plasticity of the brain over the 6 month period.
After the last session, patients will complete a questionnaire describing their daily activity. The researchers will see whether the changes recorded in brain plasticity predict the improvements in daily activity the patients have made.
It is predicted that fluoxetine will show an overall benefit to stroke patients’ recovery, and it is hoped this study will help explain its mechanism of action. Understanding how the drug affects the brain will be vital in the design and selection of new therapies and determining which patients are likely to benefit most from this approach.
1 February 2015