Turkeltaub 2017.
| Methods | Randomised controlled double blind trial | |
| Participants | Country: USA 38 people above the age of 18 with aphasia due to left hemisphere stroke (diagnosed by a physician or speech‐language pathologist) Exclusion criteria: skull defect at or near the site of tDCS delivery, history of a significant stroke or traumatic brain injury additional to the event that caused the aphasia, history of other brain conditions that could impact interpretation of results (such as multiple sclerosis, brain tumour, encephalitis, premorbid dementia), presence of metallic devices in the head, psychiatric history, pregnancy, severe comprehension deficits Additional exclusion criteria for the optional MRI portion of the study: presence of metal in the body (except titanium), claustrophobia |
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| Interventions | 2 arms; either ‐ Dual‐tDCS with the anodal electrode placed over the left hemisphere and the cathodal electrode placed over the right hemisphere at the beginning of each speech and language training session for 5 days a week for 1 week, or ‐ S‐tDCS at the beginning of each speech and language training session for 5 days a week for 1 week during 60 minutes of naming treatment sessions |
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| Outcomes | Primary outcome measures: WAB‐R: Naming and Word Finding score (change from baseline to 1 day after intervention period) Secondary outcome measures: ‐ WAB‐R: spontaneous speech, repetition, auditory verbal comprehension and overall AQ immediately; 2 weeks after the end of intervention phase; 12 weeks after the end of intervention phase ‐ PNT immediately; 2 weeks after the end of intervention phase; 12 weeks after the end of intervention phase ‐ BDAE: verbal agility subtest immediately; 2 weeks after the end of intervention phase; 12 weeks after the end of intervention phase ‐ Subjective assessments including: CETI, Stroke and Aphasia Quality of Life Scale, and Stroke Aphasic Depression Questionnaire, immediately; 2 weeks after the end of intervention phase; 12 weeks after the end of intervention phase ‐ Cognitive‐Linguistic Quick Test immediately; 2 weeks after the end of intervention phase; 12 weeks after the end of intervention phase ‐ Reading assessments immediately; 2 weeks after the end of intervention phase; 12 weeks after the end of intervention phase ‐ Motricity Index immediately; 2 weeks after the end of intervention phase; 12 weeks after the end of intervention phase |
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| Notes | Study description and results were published on the clinicaltrials.gov website | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described by the study authors |
| Allocation concealment (selection bias) | Unclear risk | Not described by the study authors |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Quote: "[Blinding:] Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "[Blinding:] Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)" |
| Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | 1 out of 24 (4%) participants in the experimental group was lost to follow‐up (reason not stated) and 0 out of 14 (0%) participants in the control group dropped out. 1 out of 23 patients (4%) of the experimental group and 1 out of 14 (7%) have been excluded from analysis (reason not stated) |
| Selective reporting (reporting bias) | High risk | All outcome measures listed in the protocol (except BDAE) have been reported |
| Other bias | Low risk | Results were published on the clinicaltrials.gov website |