NCT04142866 · City University of New York
Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia
What this study is about
The purpose of this study is to assess changes in language abilities of participants with chronic, post-stroke aphasia following an 8-week therapy period combined with brain stimulation. The investigators use a stimulation method called transcranial direct current stimulation (tDCS).
View original scientific description
The purpose of this study is to assess changes in language abilities of participants with chronic, post-stroke aphasia following an 8-week therapy period combined with brain stimulation. The investigators use a stimulation method called transcranial direct current stimulation (tDCS). The investigators cover two electrodes in damp sponges, place them on the scalp, and pass a weak electrical current between them. Some of this current passes through the brain and can change brain activity. One electrode is placed over language areas a bit above and in front of the left ear. The other is placed on the forehead above the right eye. Stimulation is provided twice a week for 8 weeks during aphasia therapy. The investigators believe that this stimulation may increase the effectiveness of therapy.
Interventions
DEVICE
Anodal transcranial direct current stimulation
2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the active tDCS condition, stimulation continues for the first 20 minutes of the 60-minute treatment session, and then ramps back down to 0 milliamps (mA).
DEVICE
Sham transcranial direct current stimulation
2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the sham tDCS condition, the current is only on for 30 seconds before it is ramped back down to 0 milliamps (mA), although the electrodes are still worn for 20 minutes.
BEHAVIORAL
Speech-Language Therapy (SLT)
Therapy provided is Verb Network Strengthening Treatment (VNeST). Therapy sessions last for 60 minutes and are provided twice weekly for 8 weeks. Active or sham tDCS is delivered during the first 20 minutes of therapy. The therapist is blinded to stimulation condition (active or sham).
Primary outcome measures
Production of Correct Information Units (CIUs) on Discourse Tasks
Time frame: Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up
Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, informative, and appropriate in context (Nicholas \& Brookshire, 1993).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Right handed (pre-stroke for participants with aphasia)
- High school education or equivalent
- Native English fluency without early 2nd language exposure (before age 10)
- Ability to perform the required discourse and MRI tasks (determined via in-person screening) Additional INCLUSION Criteria for participants with APHASIA:
- Single-event left hemisphere stroke \> 6 months prior to enrollment
- Aphasia diagnosis per Western Aphasia Battery-Revised
- Not receiving any other speech therapy for the entire study period (20 weeks)
- Ability to perform the required therapy tasks (determined via in-person screening)
Exclusion criteria
- Failed vision or hearing screening
- MRI contraindications (including pacemaker)
- History of seizure or change in seizure medication in past 12 months
- History of speech/language, psychiatric, or neurological disorder, or current serious medical condition (except chronic stroke comorbidities for participants with aphasia) Additional EXCLUSION criteria for participants with APHASIA are:
- Unmodifiable hair style precluding scalp contact by electrodes
- Sensitive scalp by self-report
Where
- New York, New York
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Data: ClinicalTrials.gov · synced Jan 7, 2025 · Source of record for eligibility and locations