Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy

NCT03272906 | Completed FDA Device

• 1 other identifier: LEQSF(2017-20)-RD-A-03
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Study Design: This is a within-subjects crossover design. Subjects will participate in the procedures twice, once under each condition (active vs. sham stimulation). The order of conditions will be counter-balanced across subjects. Stimulation will target ventral inferior frontal gyrus (IFG) and will be paired with standard speech-language therapy. Outcome measures will be acquired at the beginning and end of a semester of standard speech-language therapy.

Conditions

Aphasia; Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Production of Correct Information Units (CIUs) in Cinderella narrative

  Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, and appropriate in context

  Following 8 weeks of speech-language therapy

Secondary Outcomes (3)

• Western Aphasia Battery-Revised (WAB-R)

  Following 8 weeks of speech-language therapy

• Communication Activities of Daily Living-2 (CADL-2)

  Following 8 weeks of speech-language therapy

• Philadelphia Naming Test - Short Form (PNT)

  Following 8 weeks of speech-language therapy

Study Arms (2)

A-tDCS & speech-language therapy

EXPERIMENTAL

Anodal transcranial direct current stimulation (2 mA) plus speech-language 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 2mA for a maximum of 20 minutes.

Device: Anodal transcranial direct current stimulation; Behavioral: Speech-language therapy

Sham-tDCS & speech-language therapy

SHAM COMPARATOR

Sham transcranial direct current stimulation (2 mA) plus speech-language 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 mA.

Device: Sham transcranial direct current stimulation; Behavioral: Speech-language therapy

Interventions

Anodal transcranial direct current stimulation DEVICE

2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 60-minute treatment session.

Also known as: (A-tDCS)

A-tDCS & speech-language therapy

Sham transcranial direct current stimulation DEVICE

2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition.

Also known as: Sham

Sham-tDCS & speech-language therapy

Speech-language therapy BEHAVIORAL

Therapy tasks will be determined by the clinician on an individualized basis and will not be affected by this research protocol. The only difference between the clinical therapy that is normally provided in the clinic and this research paradigm is the application of tDCS electrodes during therapy. Therapist is blinded to stimulation type.

Also known as: SLT

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

Eligibility Criteria

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

You may qualify if:

• Single, unilateral stroke resulting in aphasia
• Competency to provide written informed consent
• Ability to participate in standard aphasia therapy

You may not qualify if:

• Serious psychological condition
• Serious neurological condition, other than stroke
• Serious medical condition
• Pregnancy
• History of seizures
• Presence of electronic or metal implants (e.g., pacemaker, vagal nerve stimulator, etc.).

Sponsors & Collaborators

• Louisiana State University and A&M College: lead

Study Sites (1)

Louisiana State University

Baton Rouge, Louisiana, 70803, United States

Location

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

  Lousiana State University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 2, 2017
• First Posted: September 6, 2017
• Study Start: August 31, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

US (1)