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Completed

NCT Number: NCT04963803

Improving Aphasia Using Electrical Brain Stimulation

Language and communication are essential for almost every aspect of human life, but for people who have aphasia, a language processing disorder that can occur after stroke or brain injury, even simple conversations can become a formidable challenge. Speech and language therapy can help people recover their language ability, but often requires months or even years of therapy before a person is able to overcome these challenges. This research will investigate non-invasive brain stimulation as a way to enhance the effects of speech and language therapy, which may ultimately lead to better and faster recovery from stroke and aphasia. The investigators hypothesize that participants with aphasia who receive speech and language therapy paired with active electrical brain stimulation will improve significantly more on a language comprehension task than those who receive speech and language therapy paired with sham stimulation.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse University

Syracuse, New York, 13244, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older.
  • No diagnosis of neurological disorder (other than stroke).
  • No diagnosis of psychiatric disorder.
  • No seizure within the past 6 months.
  • Not pregnant.
  • In chronic phase of recovery, defined as at least 6 months post-stroke.
  • Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study.
  • No metal implants in the head.
  • No unhealed skull fractures.
  • Onset of aphasia related to left hemisphere stroke.
  • Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex.
  • Mild to moderate aphasia.
  • Cognitive ability minimally within functional limits.
  • Able to pass vision and hearing screening (with use of corrective aids if needed; eyeglasses, hearing aids).
  • Willing to allow audio-recording of study sessions.

Exclusion criteria

  • Younger than 18 years old.
  • Diagnosis or history of neurological disorder other than stroke.
  • Diagnosis or history of psychiatric disorder.
  • History of seizures within the past 6 months.
  • Pregnant.
  • <6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study)
  • Currently undergoing speech and language therapy targeting auditory comprehension or attention.
  • Metal implants in the head.
  • Currently has a skull fracture.
  • Onset of aphasia related to etiology other than left hemisphere stroke.
  • Damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex.
  • No aphasia or severe aphasia.
  • Cognitive ability below functional limits.
  • Unable to pass vision and/or hearing screening with use of corrective aids.
  • Unwilling to allow audio-recording of study sessions.

Treatment and study plan

Active Transcranial Direct Current Stimulation (tDCS)

Device

Active transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session for 10 sessions.

Sham Transcranial Direct Current Stimulation (tDCS)

Device

Sham transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session. Participants in this arm will receive sham stimulation for 10 sessions.

Language Specific Attention Treatment

Behavioral

This is a specific type of speech-language therapy that focuses on simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this treatment.

Primary outcomes

  1. Language Specific Attention Treatment Probe

    Time frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

    Measurement of auditory comprehension for untrained sentence-level stimuli. Participants listen to a sentence and are asked to answer comprehension questions about the sentence they heard. Results are reported as the percentage of correct responses out of the total number of items administered. Higher percentages indicate better performance and less auditory comprehension impairment.

Secondary outcomes

  1. Continuous Performance Test

    Time frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

    Change in sustained attention as measured by mean reaction time on the Continuous Performance Test. Participants monitor a screen and press a button for all stimuli except a specific 'no-go' target. The value reported is the mean response time in milliseconds (ms) for correct 'go' trials; a decrease in time indicates improved processing speed.

  2. Attention Network Test

    Time frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

    The Attention Network Test (ANT) is a computerized task that measures the efficiency of three distinct attentional networks: Alerting, Orienting, and Executive (Conflict) control.

    Alerting Network Score: Calculated by subtracting the mean reaction time (RT) of double-cue trials from no-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater alerting benefit.

    Orienting Network Score: Calculated by subtracting the mean RT of spatial-cue trials from center-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater orienting benefit.

    Conflict (Executive) Network Score: Calculated by subtracting the mean RT of congruent flanker trials from incongruent flanker trials. Range: -500ms to +1000ms. Lower scores represent better executive control and less interference from distracting stimuli.

  3. Scenario Test

    Time frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

    The Scenario Test assesses daily life communication and discourse through 6 multi-modal scenarios presented via pictures. Participants are prompted to respond to specific communicative situations. Performance is scored based on the effectiveness of communication (verbal and non-verbal) for each item. Results are reported as the average percentage of correct communicative acts out of the total possible score. Range: 0% to 100%, where higher percentages indicate better functional communication and less severe impairment.

  4. Revised Token Test

    Time frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline

    The Revised Token Test assesses auditory comprehension battery; 5 subtests were administered that contributed to the total score. Results are reported as a mean of the 5 subtest scores. Range of scores is 1 to 15, higher scores represent better performance and less severe auditory comprehension impairment.

Sponsors and collaborators

Lead sponsor

Syracuse University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Improving Aphasia Outcomes Through tDCS-Mediated Attention Management

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2021
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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