At a glance
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Transcranial Direct Current Stimulation and Melodic Intonation Therapy Combined With Dextroamphetamine in Chronic Stroke Patients With Non-fluent Aphasia; Safety and Efficacy Phase
In Brief
A Phase 2 clinical trial evaluating Dexedrine, Active tDCS, and 3 other interventions for Stroke. Completed, enrolled 10 participants across 1 site.
Detailed Summary
The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine (Dexedrine) and transcranial direct current stimulation (tDCS) with melodic intonation therapy (MIT) for treatment of aphasia after stroke. The target population is patients with chronic speech deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed project will help in the design of future larger studies.The safety phase will use cross-over, placebo controlled and single-blinded design. 10 participants with post stroke chronic non-fluent aphasia will undergo two experiments. To study the safety and effect of combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups, randomized, sham and placebo controlled, and double-blinded design in which 48 participants with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1) dextroamphetamine therapy with active stimulation, 2) placebo medication with active stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication with sham stimulation for the same duration.
Study Details
Timeline
Interventions
10 mg immediate release of Dexedrine
1.5 mA tDCS anodal tDCS
60 min of speech therapy