Improving Aphasia Using Electrical Brain Stimulation

NCT04963803 | Completed Results DMC FDA Device

• 1 other identifier: 1R21DC017787-01A1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

tDCS; attention; language; speech-language therapy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Continuous Performance Test

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

• Attention Network Test

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

• Scenario Test

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

• Revised Token Test

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

Study Arms (2)

Active transcranial direct current stimulation (tDCS) paired with speech-language therapy

EXPERIMENTAL

Active 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.

Device: Active transcranial direct current stimulation (tDCS); Behavioral: Language Specific Attention Treatment

Sham transcranial direct current stimulation (tDCS) paired with speech-language therapy

SHAM COMPARATOR

Sham 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.

Device: Sham transcranial direct current stimulation (tDCS); Behavioral: Language Specific Attention Treatment

Interventions

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.

Sham transcranial direct current stimulation (tDCS) paired with speech-language therapy

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.

Active transcranial direct current stimulation (tDCS) paired with speech-language therapy; Sham transcranial direct current stimulation (tDCS) paired with speech-language therapy

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.

Active transcranial direct current stimulation (tDCS) paired with speech-language therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Syracuse University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

Location

Related Publications (11)

• 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.

  PMID: 28201833 BACKGROUND

• 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.

  PMID: 31348732 BACKGROUND

• 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.

  PMID: 30128538 BACKGROUND

• 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.

  PMID: 31300247 BACKGROUND

• 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.

  PMID: 22524787 BACKGROUND

• 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.

  PMID: 26652115 BACKGROUND

• 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.

  PMID: 18303984 BACKGROUND

• 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.

  PMID: 28279641 BACKGROUND

• 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.

  PMID: 11970796 BACKGROUND

• 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.

  PMID: 26645310 BACKGROUND

• 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.

  PMID: 27372845 BACKGROUND

MeSH Terms

Conditions

Stroke; Aphasia; Language; Communication Disorders

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; Communication; Behavior; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Study was started in 2021 and COVID significantly affected the ability to recruit and enroll eligible individuals in treatment. Final participant numbers were below our original targets, resulting in underpowered statistical tests.

Results Point of Contact

• Title: Ellyn Riley
• Organization: Syracuse University

aphasia@syr.edu

315-443-8688

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 15, 2021
• Study Start: July 12, 2021
• Primary Completion: November 15, 2024
• Study Completion: December 31, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 1 year after publication.
• Access Criteria: 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.

Locations

US (1)