Transcranial Alternating Current Stimulation in Post Stroke Aphasia Therapy (AfatES)

April 1, 2026 updated by: QVITI S.A.

Transcranial Alternating Current Stimulation in Post Stroke Aphasia Therapy. A Pilot Study

This study aims to investigate the efficacy of transcranial alternating current stimulation (tACS) combined with linguistic training for patients with chronic post-stroke aphasia. Thirteen patients will participate in a randomized crossover clinical trial. Their naming ability will be assessed before and after two-weeks of therapy (with 16 days of washout) supported by either 75Hz tACS or sham stimulation. The stimulated cortical area will be selected individually based on the results of functional magnetic resonance imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aphasia remains one of the most challenging long-term disabilities after stroke. Neuromodulation methods, such as transcranial electrical stimulation, may induce synaptic neuroplasticity processes and facilitate language restoration. Specifically, transcranial alternating current stimulation (tACS) may influence intrinsic cortical oscillations and GABA(A) inhibition.

This randomized, triple-blind, within-subject crossover pilot study aims to evaluate the feasibility and efficacy of tACS as an adjunct technique in the therapy of adults with chronic post-stroke aphasia.

Participants (>6 months post-stroke) will undergo 20 therapeutic sessions consisting of language training (with a focus on naming ability) combined with 75 Hz tACS over selected cortical areas. Stimulation targets will be identified individually prior to the first intervention session using functional magnetic resonance imaging (fMRI) during a naming task, selecting regions with the highest BOLD signal.

Participants will receive 10 sessions of active tACS and 10 sessions of sham stimulation in randomized order. Each intervention phase will last 2 weeks, resulting a total of 4 weeks of intervention. A 16-day washout period between the two intervention phases will be applied. The language training will include the vanishing cues method and a visual speech perception segment component to support language improvement and maintain a high level of participant motivation.

The primary outcome measure will be naming accuracy, assessed as the percentage of correctly named items in a picture-naming task (trained items), measured at three time points: immediately after completion of the intervention (last session), at 2-week, and 6-week follow-up.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-366
        • "Projekt Samodzielni" sp. z o.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • presence of aphasia (Broca's or mixed)
  • first ever stroke with one major lesion in left hemisphere
  • chronic stage (at least 6 months since onset)
  • right handedness
  • capability to give an informed consent
  • Native Polish speaker
  • 5-80% correct responses in the first naming task

Exclusion Criteria:

  • history of neurosurgical interventions
  • history of other neurological or psychiatric conditions (including dementia, head trauma, alcohol abuse etc.)
  • reports of seizures during last 36 months
  • serious vision disorders
  • medications increasing risk of seizures or influencing neuroplasticity
  • electrically, magnetically or mechanically activated implants or other systems sensitive to electricity in the body
  • history of language and/or speech disorders or intellectual disability in childhood
  • bilingualism
  • pregnancy
  • claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active tACS
Active transcranial alternating current stimulation combined with language tasks.
Device: active 75 Hz transcranial alternating current stimulation
Participants will recive 10 sessions of active tACS. Each session includes 40 minutes (divided into 4 portions with rest breaks in between) of alternating current application in a high gamma frequency range to the language cortex via 5x5 and 5x10 (reference) electrodes.
Other Names:
  • High gamma frequency transcranial alternating current stimulation
Sham Comparator: Sham tACS
Sham transcranial alternating current stimulation combined with language tasks.
Device: sham transcranial alternating current stimulation
Participants will recive 10 sessions of sham stimulation. Each session mimics tha active condition, with brief fade-in and fade-out periods (30 seconds) at the beginning and end of each stimulation portion, without delivering a therapeutic dose. Stimualtion is applied over the left hemisphere via 5x5 and 5x10 (reference) electrodes.
Other Names:
  • sham tACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage accuracy in a picture-naming task (trained items)
Time Frame: Assessed immediately after completion of the intervention (last session), at 2-week, and 6-week follow-up
Naming accuracy will be assessed as the percentage of correctly named items in a naming task consisting of 40 realistic pictures of nouns that participants were unable to name correctly prior to the intervention. Score will range from 0% to 100%, where 0% indicates no correct responses and 100% indicates all items named correctly. Higher scores will indicate better naming performance.
Assessed immediately after completion of the intervention (last session), at 2-week, and 6-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of electrical stimulation (pain scale)
Time Frame: after each treatment session
Pain intensity will be measured using the Wong-Baker FACES Pain Rating Scale, a validated visual analogue scale ranging from 0 to 10, where 0 indicates "no hurt" and 10 indicates "hurts worst". Higher scores will indicate greater pain intensity, reflect worse tolerability of stimulation.
after each treatment session
Number of correctly retrieved words at the highest difficulty level (no supporting cues)
Time Frame: during treatment sessions
Naming efficacy will be assessed as the absolute number of correctly retrieved words at the highest difficulty level of the anomia treatment task paired with 75 Hz tACS or sham stimulation. At this level, the target object will be presented without any supporting cues. Higher score will present a better naming performance.
during treatment sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QVITI S.A.

Investigators

  • Principal Investigator: Iwona Sarzyńska-Długosz, Institute of Psychiatry and Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/1261/19-TmpDel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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