HD-tDCS for Phonological Impairment in Aphasia

NCT06010030 | Active Not Recruiting FDA Device

• 1 other identifier: PRO00046308
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.

Conditions

Aphasia; Stroke

Outcome Measures

Primary Outcomes (1)

• Behavioral outcome

  Percent improvement on behavioral outcomes after each therapy cycle will be the primary behavioral outcome measure.

  Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post completion of therapy

Secondary Outcomes (1)

• fMRI

  3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B

Study Arms (2)

HD-tDCS

EXPERIMENTAL

Participants will be randomized to receive either anodal HD-tDCS or sham-tDCS.

Device: Targeted Transcranial Direct Current Stimulation

Speech Therapy

EXPERIMENTAL

Participants will be randomized to receive either phonologic-focused speech therapy or semantic-focused speech therapy

Behavioral: Speech Therapy

Interventions

Speech Therapy BEHAVIORAL

Participants will receive either semantic or phonological focused speech therapy

Speech Therapy

Targeted Transcranial Direct Current Stimulation DEVICE

High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. Anodal or sham tDCS will be administered.

Also known as: HD-tDCS, tDCS

HD-tDCS

Eligibility Criteria

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

You may qualify if:

• Patients must be 18 or older.
• Patients may not be older than 85.
• Patients must have a language deficit from left-sided focal neurologic damage (e.g. stroke, tumor).
• Patients must be adults and have English-language fluency.
• Patients must be eligible to undergo MRI.

You may not qualify if:

• Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease)
• Neurologic disease (e.g. idiopathic epilepsy, seizure disorders that are not well managed, Parkinson's disease, ALS),
• Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)
• Suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability).
• Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, inability to see or hear stimulus materials.
• Younger than 18 or older than 85.
• \< 6 months post tumor resection.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (34)

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MeSH Terms

Conditions

Aphasia; Stroke

Interventions

Transcranial Direct Current Stimulation; Speech Therapy

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication 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

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care provider, participant, and outcome assessor are masked for tDCS status.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will maintain one of two speech therapy modalities throughout the study and be assigned to either targeted anodal-tDCS or sham-tDCS.

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 24, 2023
• Study Start: October 3, 2023
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)