Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia
Part of paid clinical trials in New York, New York.
- Sponsor
- City University of New York
- Study ID
- NCT04142866
- Status
- Recruiting
Conditions
- Aphasia
- Stroke
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 80 Years
- Healthy Volunteers
- Accepted
Interventions
- Anodal transcranial direct current stimulation — DEVICE2 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).
- Sham transcranial direct current stimulation — DEVICE2 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.
- Speech-Language Therapy (SLT) — BEHAVIORALTherapy 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).
Study Details
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.
Key Dates
- Start date
- Jan 3, 2025
- Status verified
- Jan 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: A-tDCS & speech-language therapyAnodal transcranial direct current stimulation (2 milliamps \[mA\]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2 milliamps (mA) for a maximum of 20 minutes.
- Sham Comparator: Sham-tDCS & speech-language therapySham transcranial direct current stimulation (2 milliamps \[mA\]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 milliamps (mA).
Primary Outcome Measure
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 ]
Central Contacts
- E. Susan Duncan, PhD, CCC-SLP212 817 8804
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City University of New York | New York | New York | 10016 | E. Susan Duncan, PhD, CCC-SLP (PRINCIPAL_INVESTIGATOR) |
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