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StrokeNCT04963803

Improving Aphasia Using Electrical Brain Stimulation

A study testing Active transcranial direct current stimulation (tDCS) and Language Specific Attention Treatment in people with Stroke and Aphasia, run by Syracuse University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Aphasia
What is being tested?
Active transcranial direct current stimulation (tDCS) and Language Specific Attention Treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteUnited States
Study dates
12 Jul 2021to 31 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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)
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Syracuse University

    Syracuse, New York, 13244

Other trials in United States

About this study

Official title: Improving Aphasia Outcomes Through tDCS-Mediated Attention Management

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.

Conditions
Stroke, Aphasia
Being tested
Active transcranial direct current stimulation (tDCS), Sham transcranial direct current stimulation (tDCS), Language Specific Attention Treatment
Keywords
tDCS, attention, language, speech-language therapy
Medical subject headings
Stroke, Aphasia, Language, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 TreatmentBehavioural

    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.

Study groups in NCT04963803
Study groupRoleWhat they receive
Active transcranial direct current stimulation (tDCS) paired with speech-language therapyExperimentalActive transcranial direct current stimulation (tDCS) 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 with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Receives: Device: Active transcranial direct current stimulation (tDCS); Behavioral: Language Specific Attention Treatment
Sham transcranial direct current stimulation (tDCS) paired with speech-language therapySham comparatorSham transcranial direct current stimulation (tDCS) 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 with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.
Receives: Device: Sham transcranial direct current stimulation (tDCS); Behavioral: Language Specific Attention Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Language Specific Attention Treatment Probe

    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.

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

Secondary outcomes (4)
  1. Continuous Performance Test

    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.

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

  2. Attention Network Test

    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.

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

  3. Scenario Test

    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.

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

  4. Revised Token Test

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start12 Jul 2021
  3. Primary completion15 Nov 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04963803
Sponsor's protocol ID
1R21DC017787-01A1
Other IDs
1R21DC017787-01A1
Status last verified
Jan 2026
First submitted
21 Jun 2021
Last updated
30 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The final dataset will include self-reported demographic data (e.g., age, race, gender), medical information related to participant's stroke (e.g., date of onset, lesion location), and behavioral data obtained from cognitive and language tasks administered in the Syracuse University Aphasia Lab as part of the study. The final computerized dataset will be stripped of all personal identifiers. The investigators will make the data and associated documentation available to users only via a signed data-sharing agreement that stipulates a commitment to: (1) only use the data for research purposes and not to identify any individual participants, (2) securely storing the data via password-protected databases and secure servers, and (3) destroying or returning the data after analyses are completed. Data sharing will be available upon publication of the main study findings.

Publications

  • Peach RK, Nathan MR, Beck KM. Language-Specific Attention Treatment for Aphasia: Description and Preliminary Findings. Semin Speech Lang. 2017 Feb;38(1):5-16. doi: 10.1055/s-0036-1597260. Epub 2017 Feb 15.

    PubMed 28201833
  • Peach RK, Beck KM, Gorman M, Fisher C. Clinical Outcomes Following Language-Specific Attention Treatment Versus Direct Attention Training for Aphasia: A Comparative Effectiveness Study. J Speech Lang Hear Res. 2019 Aug 15;62(8):2785-2811. doi: 10.1044/2019_JSLHR-L-18-0504. Epub 2019 Jul 25.

    PubMed 31348732
  • Fridriksson J, Rorden C, Elm J, Sen S, George MS, Bonilha L. Transcranial Direct Current Stimulation vs Sham Stimulation to Treat Aphasia After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1470-1476. doi: 10.1001/jamaneurol.2018.2287.

    PubMed 30128538
  • Riley EA, Wu Y. Artificial grammar learning with transcranial direct current stimulation (tDCS): A pilot study. Brain Stimul. 2019 Sep-Oct;12(5):1307-1308. doi: 10.1016/j.brs.2019.07.002. Epub 2019 Jul 2. No abstract available.

    PubMed 31300247
  • Petersen SE, Posner MI. The attention system of the human brain: 20 years after. Annu Rev Neurosci. 2012;35:73-89. doi: 10.1146/annurev-neuro-062111-150525. Epub 2012 Apr 12.

    PubMed 22524787
  • Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22.

    PubMed 26652115
  • Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.

    PubMed 18303984
  • Chhatbar PY, Chen R, Deardorff R, Dellenbach B, Kautz SA, George MS, Feng W. Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study. Brain Stimul. 2017 May-Jun;10(3):553-559. doi: 10.1016/j.brs.2017.02.007. Epub 2017 Feb 27.

    PubMed 28279641
  • Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.

    PubMed 11970796
  • Ishigami Y, Eskes GA, Tyndall AV, Longman RS, Drogos LL, Poulin MJ. The Attention Network Test-Interaction (ANT-I): reliability and validity in healthy older adults. Exp Brain Res. 2016 Mar;234(3):815-27. doi: 10.1007/s00221-015-4493-4. Epub 2015 Dec 8.

    PubMed 26645310
  • Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.

    PubMed 27372845

Questions about this trial

What is this clinical trial studying?

A study testing Active transcranial direct current stimulation (tDCS) and Language Specific Attention Treatment in people with Stroke and Aphasia, run by Syracuse University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04963803, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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