Monti 2008a.
Methods | Randomised sham‐controlled cross‐over trial | |
Participants | Country: Italy 8 right‐handed chronic non‐fluent aphasic patients (4 women), age in years (mean ± SD, 60.38 ± 11.99), education in years (mean ± SD, 10.62 ± 4.86), mean time from stroke onset to study entry 3.93 ± 1.89 years Inclusion criteria: not stated Exclusion criteria: severely impaired auditory verbal comprehension (Token Test < 8), severe apraxia of speech, seizures in the last 12 months, psychiatric disease and dementia |
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Interventions | Each participant underwent 2 different treatment conditions (A: A‐tDCS 2 mA; B: C‐tDCS 2 mA; C: S‐tDCS. Each for 10 minutes over the left Broca's region, order of intervention randomised) in the following order: ‐ picture‐naming task + A or C, at least 7 days rest period, picture‐naming task + C or A ‐ picture‐naming task + B or C, at least 7 days rest period, picture‐naming task + C or B |
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Outcomes | Outcomes were reported at baseline and at the end of intervention phase: ‐ naming accuracy in per cent (continuous; ranging from 0 to 100 with a higher value indicating better performance) ‐ reaction time for naming pictures (0 to infinity with a lower value indicating better performance) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Microsoft Excel random number generator (Priori 2012 [pers comm]) |
Allocation concealment (selection bias) | Low risk | A third person, uninvolved in the rest of the experiment, assigned participants to their stimulation groups (Priori 2012 [pers comm]) |
Blinding of participants and personnel (performance bias) Objective outcomes | Unclear risk | Objective outcome measures: participants were blinded, whereas personnel were not |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Outcome assessor was unaware of stimulation type |
Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Objective outcomes: all participants completed the study. No treatment withdrawals, no trial group changes and no major adverse events stated |
Selective reporting (reporting bias) | Unclear risk | All outcomes listed in the 'Methods' section reported; no published protocol could be identified |
Other bias | Low risk | No other bias identified |