Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia

NCT04142866 | Recruiting FDA Device

• 1 other identifier: 2023-0605-GC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aphasia; Stroke

Keywords

aphasia; stroke; tDCS; language; stimulation; brain; speech therapy

Outcome Measures

Primary Outcomes (1)

• Production of Correct Information Units (CIUs) on Discourse Tasks

  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).

  Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up

Secondary Outcomes (2)

• Western Aphasia Battery-Revised

  Collected once at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up

• Boston Naming Test

  Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up

Study Arms (2)

A-tDCS & speech-language therapy

EXPERIMENTAL

Anodal 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.

Device: Anodal transcranial direct current stimulation; Behavioral: Speech-Language Therapy (SLT)

Sham-tDCS & speech-language therapy

SHAM COMPARATOR

Sham 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).

Device: Sham transcranial direct current stimulation; Behavioral: Speech-Language Therapy (SLT)

Interventions

Anodal transcranial direct current stimulation DEVICE

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).

Also known as: A-tDCS

A-tDCS & speech-language therapy

Sham transcranial direct current stimulation DEVICE

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.

Also known as: Sham

Sham-tDCS & speech-language therapy

Speech-Language Therapy (SLT) BEHAVIORAL

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).

Also known as: SLT

A-tDCS & speech-language therapy; Sham-tDCS & speech-language therapy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• Failed vision or hearing screening
• MRI contraindications (including pacemaker)
• Pregnancy
• 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)
• Unmodifiable hair style precluding scalp contact by electrodes
• Sensitive scalp by self-report

Sponsors & Collaborators

• City University of New York: lead

Study Sites (1)

City University of New York

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Aphasia; Stroke; Language; Communication Disorders

Interventions

Transcranial Direct Current Stimulation; Speech Therapy

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Communication; Behavior; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• E. Susan Duncan, PhD, CCC-SLP

  City University of New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

E. Susan Duncan, PhD, CCC-SLP

CONTACT

212 817 8804; esduncan@gc.cuny.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: January 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: The investigators plan to post data following conclusion of this study (anticipated 12/31/2026). The shared data will be available in perpetuity.
• Access Criteria: Data will be available on OpenNeuro database: https://openneuro.org/ Accessing data on OpenNeuro requires sign in with Google or ORCID (Open Researcher and Contributor ID; https://orcid.org/).

Locations

US (1)