Non-invasive brain stimulation in Stroke patients (NIBS): A prospective randomized open blinded end-point (PROBE) feasibility trial using transcranial direct current stimulation (tDCS) in post-stroke hemispatial neglect.
Gemma Learmonth, Christopher S Y Benwell, Gesine Märker and 7 others
PMID 32498606WHAT IT FOUND
A trial of brain stimulation and rod-balancing for post-stroke neglect failed to recruit enough patients.
Only 24 were randomized instead of the planned 60, so no statistical conclusions about treatment effectiveness could be drawn.
Key findings
01Recruitment was too low to assess effectiveness, with only 24 participants randomized out of a planned 60.
02The primary reason for poor recruitment was that significant co-morbidity prevented patients from attending 10 intervention sessions.
03Because of the low sample size, the researchers were unable to perform robust statistical tests on the secondary outcome measures.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTsWhat it means for SLPs
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What it does not show
The study was a feasibility trial, not an efficacy trial, and was underpowered to detect clinical effects. Recruitment was severely limited by strict inclusion criteria and the burden of attending 10 sessions, leading to a sample that may not represent all neglect patients. The small sample size prevented robust statistical analysis of secondary outcomes. Participants and therapists were not blinded to the treatment allocation, though outcome assessors were blinded.
Declared interests
The work was funded by the Chief Scientist Office (ETM353). No other conflicts of interest are reported.
The easy way to misread this
Do not interpret the numerical changes in individual participants' scores as evidence that tDCS or behavioural training works. The study was stopped early due to low recruitment and explicitly states that robust statistical tests could not be performed, meaning no conclusion about effectiveness can be drawn from these data.