NCT01686373

Brain Stimulation and Aphasia Treatment

Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the changes in language processing of patients with chronic, post-stroke aphasia following the application of brain stimulation. The brain stimulation the investigators administer is called transcranial direct current stimulation (tDCS). It involves passing a weak electrical current through the brain between two electrodes in the form of damp sponges. One sponge will be placed over a specified area on the damaged left hemisphere, while the other sponge will be placed on the right scalp. Computer-controlled speech-language treatment will be administered during the application of tDCS.

Detailed description

Stroke is the leading cause of adult disability in the United States. Approximately one-third of all strokes result in acute language impairment (aphasia), with approximately one-fifth suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic aphasia remains grim, as current behavioral treatment approaches usually offer only limited-to-modest benefit. Recent advancements in understanding the relationship between low current electrical brain stimulation and cortical plasticity suggest that the effect of behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the effect of behavioral aphasia treatment. Based on these results as well as our other studies aimed at understanding how favorable brain plasticity correlates with positive treatment outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility design. Consistent with the goals of Program Announcement PAR-08-204 by the National Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether there is sufficient evidence of short term improvement in humans to justify a phase III trial."

Conditions

• Aphasia

Interventions

Type	Name	Description
DEVICE	Activa Dose II Real tDCS	20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)
DEVICE	Activa Dose II Sham tDCS	20 minutes of sham stimulation per treatment day (15 total sessions)

Timeline

• Start date: 2012-04-01
• Primary completion: 2017-05-01
• Completion: 2017-10-01
• First posted: 2012-09-18
• Last updated: 2019-08-20
• Results posted: 2019-08-20

Locations

2 sites across 1 country: United States