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Clinical Trial Summary

Approximately one million people in the United States are living with aphasia, an acquired neurologic disorder affecting the ability to use and/or understand language. This communication impairment affects up to 40% of stroke patients. Stroke victims usually prioritize speaking, writing, and walking as the three most important rehabilitation goals, two of these goals therefore involving communication. Conventional speech therapy strategies have nevertheless limited effectiveness in post-stroke aphasia. Indeed, approximately half of those affected will remain in this state despite intensive speech therapy. Effective novel treatment is therefore warranted to improve recovery in these patients.

Clinical Trial Description

A double-blind randomized controlled design will be conducted. Participants will randomly be assigned either to the tDCS group or to the sham (placebo) group. The only person knowing about this assignment will be the research coordinator. Both groups will include five consecutive days of 20 minutes session. Behavioral, EEG and DTI MRI data acquisition will be performed within a week before/after the tDCS/sham intervention. Behavioral measures will be performed again 3 months following tDCS/sham treatment to assess long-term benefits.

Using a B-Alert wireless EEG system, the investigators will perform electrophysiological recordings and EEG resting state with eyes open. Each recording session should last less than an hour (including set up time). Fast and Fourier power spectrum analyses will be performed using EEGLAB.

MRI scan will be acquired on the Siemens Magnetom Verio 3T at the Casa Colina Diagnostic Imaging Center using (i) T1-weighted (MPRAGE), and (ii) Diffusion Tensor Imaging (DTI) in order to assess changes in terms of structural connectivity. Each recording session should last an hour (including set up time). Data will be analyzed in collaboration with Prof. M. Monti, UCLA Department of Psychology, using FMRIB Software Library (FSL).

Behavioral assessment will be performed by a trained speech therapist and will include outcome measures such as the Western Aphasia Battery (WAB), the Montreal Cognitive Assessment (MOCA), the Communication Outcomes after Stroke (COAST), and the PROMIS Scale (v1.2 - Global Health). Each assessment session should last an hour. Behavioral data will be analyzed using SPSS.

A follow up assessment will be performed by phone or in person 6 months after completion of the study using the Glasgow Outcome Scale Extended (GOSe). This interview should last around 30 minutes. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03699930
Study type Interventional
Source Casa Colina Hospital and Centers for Healthcare
Contact Caroline Schnakers
Phone 909-596-7733
Status Recruiting
Phase N/A
Start date January 1, 2018
Completion date January 1, 2020

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