Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Aphasia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

tDCS Implementation: 2mA of direct current for 20 minutes will be delivered using a constant current stimulator via two electrodes in saline soaked sponges. To stimulate the left angular gyrus, a cathodal electrode inside a saline soaked sponge (5 x 3cm) will be placed over the CP5 according to the ...

tDCS Implementation: 2mA of direct current for 20 minutes will be delivered using a constant current stimulator via two electrodes in saline soaked sponges. To stimulate the left angular gyrus, a cathodal electrode inside a saline soaked sponge (5 x 3cm) will be placed over the CP5 according to the 10-20 international system for EEG electrode placement. The electrodes will be secured in position by a custom-built EEG cap that will be marked with the location for angular gyrus. The investigators will then confirm that the cathodal electrode is over the left angular through the use of neuronavigation. The "return" anode electrode will be placed in a saline soaked sponge (5 x 5cm) on the center of the supraorbital region. At the beginning of the tDCS, current will slowly ram-up during the first few seconds until it reaches 2mA. The ramp-up process will acclimate the participants to tDCS-induced sensations (e.g., itching). At the end of the tDCS sessions, current will slowly ramp down in the last few seconds to 0mA. The total duration of the 2mA current will be maintained for 20 minutes. For sham stimulation, the investigators will place the electrodes in the same location as the real tDCS groups with stimulation ending after few seconds. The brief stimulation will produce tDCS-induced sensations so that participants will not be aware when the tDCS stopped delivering direct current Speech-Language Treatment: Standard-of-care treatment - script training will be used to provide SLT to our participants. The treatment will be delivered via a computer program, Aphasia Scripts ®, whereby a virtual therapist interactively guides the participants through treatment steps. Scripts will be five to ten sentences and developed from common templates about topics relevant to daily life (e.g., asking questions at the grocery store, ordering in a restaurant). The advantage of using a computer program instead of a human therapist is that it removes extraneous variables associated with human therapists (e.g., different levels of encouragement) and this, together with the use of script templates, ensures treatment fidelity across participants. Duration of an individual subject's participation in the study: Subjects will be requested to come for baseline sessions (3 to 4 hours) before the actual experiment. The baseline assessments may be done over two visits. In the baseline session the subjects' aphasia severity will be assessed. The participants will also perform baseline tasks of language and cognition in this session. Subjects will then participate in 3 weeks of tDCS and SLT (i.e., 15 sessions). The sessions will consist of 40 minutes of SLT and 20 minutes of tDCS. Subjects will be asked to return for an assessment immediately following the end of treatment and for follow-up testing after 4 and 8 weeks. Therefore, total number of visits will be 19-23 sessions (depending on how many visits are needed for the assessments) over a period of three months.

Tracking Information

NCT #
NCT03773406
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
Principal Investigator: Leora Cherney, PhD Shirley Ryan AbilityLab