Abstract | Importance: Objective: To examine the futility of studying A- tDCS as an adjunctive intervention during speech therapy to improve speech production (naming) for individuals with long-term poststroke aphasia. Design, Setting, and Participants: Double-blinded, prospective randomized clinical trial using a futility design to test adjunctive A- tDCS during speech therapy. The setting was an outpatient clinic. Enrollment of individuals began in August 2012 and was completed in March 2017, and the duration of follow-up was 6 months. Analyses began in April 2017. The study recruited from a volunteer sample, and 89 patients were screened. Patients with long-term (>6 months) aphasia due to 1 previous left hemisphere stroke were enrolled. In comparing A- tDCS and sham tDCS, patients were matched based on site (University of South Carolina or Medical University of South Carolina), baseline age, type of aphasia, and aphasia severity. Interventions: Outpatient speech therapy for 3 weeks (15 sessions, 45 minutes each) combined with either A- tDCS vs sham tDCS applied to preserved left temporal lobe regions. Main Outcomes and Measures: The primary outcome was the ability to name common objects, assessed twice before and after therapy. Results: A total of 74 patients were enrolled. Participants had a mean (SD) age of 60 (10) years, had 15 (2) years of education, and were 44 (40) months from stroke onset. There were 52 men (70%) and 62 non-Hispanic white individuals (84%). Most were retired or not employed (59 [80%]). Broca aphasia was the most common aphasia type (39 [52.7%]). The adjusted mean (SE) change from pretreatment baseline in correct naming was 13.9 (2.4) words (95% CI, 9.0-18.7) for A- tDCS and 8.2 (2.2) words (95% CI, 3.8-12.6) for sham tDCS, with mean (SE) A- tDCS difference of 5.7 (3.3) words (95% CI, -0.9 to 12.3), indicating a relative 70% increase in correct naming for A- tDCS relative to sham. The futility hypothesis P value was .90, indicating failure to reject the null hypothesis and, therefore, providing no evidence that further study of A- tDCS is futile. No serious adverse events were associated with A- tDCS. Conclusions and Relevance: Our findings provide motivation to proceed with another trial to study the effect of A- tDCS on the outcome of aphasia treatment in individuals poststroke. Anodal tDCS during speech therapy is feasible and potentially transformative for aphasia treatment and should be further studied. Trial Registration: ClinicalTrials.gov Identifier: NCT01686373.
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Authors | Julius Fridriksson, Chris Rorden, Jordan Elm, Souvik Sen, Mark S George, Leonardo Bonilha |
Journal | JAMA neurology
(JAMA Neurol)
Vol. 75
Issue 12
Pg. 1470-1476
(12 01 2018)
ISSN: 2168-6157 [Electronic] United States |
PMID | 30128538
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
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Topics |
- Aged
- Aphasia
(etiology, therapy)
- Aphasia, Broca
(etiology, therapy)
- Combined Modality Therapy
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Outcome Assessment, Health Care
- Placebos
- Research Design
- Speech Therapy
(methods)
- Stroke
(complications, therapy)
- Temporal Lobe
(physiology)
- Transcranial Direct Current Stimulation
(methods)
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