TOPS: Transcranial direct-current stimulation (tDCS) to optimise participation in stroke rehabilitation – a sham controlled cross over study

This pilot study will explore the effect of a type of non-invasive brain stimulation on the ability of older adult stroke survivors to participate in inpatient rehabilitation therapy. Clinicians in the stroke unit at Bentley Health Service (BHS) have identified that after a stroke, many people complain of feeling fatigued and being unable to concentrate during their therapy sessions. This is a problem since rehabilitation is typically offered only in the initial months post stroke, and therefore it is essential that patients are able to take best advantage of the available therapy during their inpatient stay. Fatigue is common post stroke, and is a complex impairment which may be partly due to reduced excitability of parts of the brain. Research has suggested that a type of non-invasive brain stimulation called ‘transcranial direct current stimulation’ (tDCS), in combination with therapy, can increase brain activity which may facilitate recovery after a stroke. All stroke admissions to BHS would be screened for eligibility, and consenting individuals will be randomly allocated to receive tDCS or sham tDCS for 10 days (20 minutes immediately prior to 10 therapy sessions), then cross over to the other group for a matched duration and number of sessions. Only the person applying tDCS will be aware of group allocation. The primary measures will be whether the first therapy session of the day is completed as intended. The duration of this session will be recorded, along with reason(s) for failure to complete the session. This outcome has been chosen as it is unambiguous, addresses the identified clinical problem and is an important surrogate of rehabilitation outcomes. Secondary measures will be patient reported fatigue using the Fatigue Assessment Scale, alertness/vigilance measured using the Go/NoGo test and alertness (numerical rating scale) reported by staff at set times during the day. It is hypothesized that patients receiving tDCS will be more likely, at the end of the series of ten tDCS sessions, to remain alert and engaged for the planned duration of the therapy session immediately following tDCS, perform better on a test of alertness, report feeling less fatigued and be observed by staff to be more alert during the day, than those receiving an equal number of sham tDCS sessions.