Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.

NCT04432883 | Recruiting FDA Device

• 3 other identifiers: UNM HRRC #16-0911P20GM109089-01A1R01DC018282
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined semantic feature analysis/phonological components analysis treatment will be paired with the stimulation. Two assessment sessions will be pretreatment, 1 session immediately post-treatment, and 1 session at 3 months follow-up.

Conditions

Stroke; Aphasia

Keywords

Stroke; Aphasia; brain stimulation; communication problems; speech and language therapy

Outcome Measures

Primary Outcomes (3)

• Picture Naming of trained items

  Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement

  3 months

• Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)

  Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, \& Railford, 2008)

  3 months

• Naming Efficiency of trained items

  Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency

  3 months

Secondary Outcomes (5)

• Discourse informativeness - Main Concept Production

  3 months

• Efficiency of discourse informativeness - Main Concept Production

  3 months

• Picture Naming of untrained items - Boston Naming Test

  3 months

• Naming Response Time of untrained items - Boston Naming Test

  3 months

• Naming Efficiency of untrained items - Boston Naming Test

  3 months

Study Arms (2)

Experimental: Active cathodal tDCS + Speech-language training

ACTIVE COMPARATOR

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.

Device: Active Comparator: Experimental: Active cathodal tDCS + language training

Comparator: Placebo cathodal tDCS + Speech-language training

SHAM COMPARATOR

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..

Behavioral: Sham Comparator: Placebo cathodal tDCS + Speech and language

Interventions

Active Comparator: Experimental: Active cathodal tDCS + language training DEVICE

Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli. Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment.

Also known as: Behavioral: Speech and Language Training

Experimental: Active cathodal tDCS + Speech-language training

Sham Comparator: Placebo cathodal tDCS + Speech and language BEHAVIORAL

Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .

Comparator: Placebo cathodal tDCS + Speech-language training

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 25-85
• must be greater than 6 months post-stroke
• must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production
• must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left hemisphere damage
• must be stimulable for naming

You may not qualify if:

• comorbid neurological disease.
• damage to the anterior right hemisphere.
• significant mood disorder.
• substance/alcohol dependence or abuse within the past year
• presence of any implanted electrical device or contraindications to tDCS or MRI
• recent medical instability (within 4 weeks)
• pregnancy

Sponsors & Collaborators

• University of New Mexico: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of New Mexico Center for Brain Recovery and Repair

Albuquerque, New Mexico, 87106, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Aphasia; Communication Disorders

Interventions

Language Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Jessica Richardson, Ph.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Richardson, Ph.D.

CONTACT

505 277-1765; jdrichardson@unm.edu

Honey Hubbard

CONTACT

505-433-7766; hhubbard@unm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: SOM Neurosurgery

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: June 16, 2020
• Study Start: October 18, 2022
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)