Treatment Outcomes With tDCS in Post-Stroke Aphasia

NCT03929432 | Recruiting DMC FDA Device

• 1 other identifier: 207342
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose this study is to test the utility of pairing external neuromodulation with behavioral language treatment to boost therapy outcomes and to investigate the mechanisms associated with recovery. Because all PWA have word retrieval deficits, this project will test if greater language gains can be achieved by supplementing anomia intervention with excitatory brain stimulation to the left hemisphere and will evaluate associated functional brain changes to aid the optimization of neural reorganization to facilitate language processing.

Conditions

Aphasia

Outcome Measures

Primary Outcomes (1)

• Change in correct naming of nouns on Philadelphia Naming Test.

  Naming gains for untreated items.

  Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion

Secondary Outcomes (1)

• Change in correct naming of verbs on Action Naming Test

  Immediately after 1st and 2nd treatment phases and at 10 follow up after study completion

Study Arms (2)

Active tDCS (with Speech-Language Treatment)

ACTIVE COMPARATOR

tDCS Stimulation Dose: 1.5 mA for 20-mins

Device: Active Transcranial Direct Current Stimulation with SLT

Sham tDCS (with Speech-Language Treatment)

SHAM COMPARATOR

No tDCS stimulation

Device: Sham Transcranial Direct Current Stimulation with SLT

Interventions

Active Transcranial Direct Current Stimulation with SLT DEVICE

Soterix Medical 1×1 transcranial Direct Current Stimulator for Clinical Trials (1x1 tDCS-CT). Excitatory stimulation to the left hemisphere will be achieved through a 1x1 montage utilizing two carbon-rubber electrodes and 5x7 EASY pad sponges (A-tDCS \[excitatory\]left target; C-tDCS \[inhibitory\]right hemisphere). Each PWA will have a unique 5-digit tDCS program code for each treatment phase. One code will instruct the 1x1 tDCS-CT to administer active stimulation as describe above (i.e., 1.5 mA for 20 min). The other will administer 1.5 mA for only a few seconds to simulate active stimulation. SLT will consist of Semantic Feature Analysis, Phonological Component Analysis, and Verb Network Strengthening Treatment

Active tDCS (with Speech-Language Treatment)

Sham Transcranial Direct Current Stimulation with SLT DEVICE

Control condition in which only SLT is administered.Participant receives 1.5 mA for only a few seconds to simulate active stimulation, then the stimulation will cease. SLT will consist of Semantic Feature Analysis, Phonological Component Analysis, and Verb Network Strengthening Treatment

Sham tDCS (with Speech-Language Treatment)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of post-stroke aphasia
• Single left hemisphere stroke etiology
• At least 6 months post-stroke
• Age range between 18 and 80 years old
• Speak English as a native language
• Adequate hearing and vision to complete the tasks

You may not qualify if:

• Severe auditory comprehension deficits (determined by pretest) (i.e., global aphasia, Wernicke's aphasia, transcortical sensory aphasia)
• Inability to provide informed consent
• Co-occurring history of neurological disease/disorder/injury (e.g., traumatic brain injury, right hemisphere stroke, dementia)
• Co-occurring history of a major mental illness (e.g., schizophrenia, drug addiction, bipolar)
• Clinical conditions contraindicated for MRI or tDCS (e.g., implanted electrical devices, claustrophobia, seizure disorder)
• Positive pregnancy test (for females)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dana Moser, PhD, CCC-SLP

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Moser, PhD, CCC-SLP

CONTACT

501-569-8914; DRMoser@uams.edu

Portia Carr

CONTACT

501-569-3155; PSCarr@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active tDCS versus sham tDCS will be masked to the participants
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 26, 2019
• Study Start: September 3, 2019
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)