StrokeAfatESNCT07510464
Transcranial Alternating Current Stimulation in Post Stroke Aphasia Therapy
A study testing active 75 Hz transcranial alternating current stimulation in people with Stroke and Aphasia, run by QVITI S.A. at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- active 75 Hz transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- history of language and/or speech disorders or intellectual disability in childhood
- bilingualism
- pregnancy
- claustrophobia
Trial locations and contacts
1 site in 1 country.
Poland1 site
"Projekt Samodzielni" sp. z o.o.
Warsaw, Masovian Voivodeship, 02-366
About this study
Official title: 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.
Read the 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.
- Being tested
- active 75 Hz transcranial alternating current stimulation, sham transcranial alternating current stimulation
- Keywords
- non-invasive brain stimulation, transcranial alternating current stimulation, neurorehabilitation
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active 75 Hz transcranial alternating current stimulationDevice
Also called High gamma frequency 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.
sham transcranial alternating current stimulationDevice
Also called sham tACS
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tACS | Experimental | Active transcranial alternating current stimulation combined with language tasks. Receives: Device: active 75 Hz transcranial alternating current stimulation |
| Sham tACS | Sham comparator | Sham transcranial alternating current stimulation combined with language tasks. Receives: Device: sham transcranial alternating current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage accuracy in a picture-naming task (trained items)
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.
Measured: Assessed immediately after completion of the intervention (last session), at 2-week, and 6-week follow-up
Secondary outcomes (2)
Tolerability of electrical stimulation (pain scale)
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.
Measured: after each treatment session
Number of correctly retrieved words at the highest difficulty level (no supporting cues)
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.
Measured: during treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Dec 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- QVITI S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iwona Sarzyńska-Długosz, Principal investigator, Institute of Psychiatry and Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510464
- Sponsor's protocol ID
- KB/1261/19-TmpDel
- Acronym
- AfatES
- Status last verified
- Apr 2026
- First submitted
- 28 Nov 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 30128538Nowak M, Hinson E, van Ede F, Pogosyan A, Guerra A, Quinn A, Brown P, Stagg CJ. Driving Human Motor Cortical Oscillations Leads to Behaviorally Relevant Changes in Local GABAA Inhibition: A tACS-TMS Study. J Neurosci. 2017 Apr 26;37(17):4481-4492. doi: 10.1523/JNEUROSCI.0098-17.2017. Epub 2017 Mar 27.
PubMed 28348136
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Alternating Current Stimulation in Post Stroke Aphasia Therapy. A Pilot Study
- ClinicalTrials.gov ID
- NCT07510464
- Acronym / sponsor ID
- AfatES / KB/1261/19-TmpDel
- Keywords
- non-invasive brain stimulation, transcranial alternating current stimulation, neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- QVITI S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tACS | Experimental | Device: active 75 Hz transcranial alternating current stimulationActive transcranial alternating current stimulation combined with language tasks. |
| Sham tACS | Sham comparator | Device: sham transcranial alternating current stimulationSham transcranial alternating current stimulation combined with language tasks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active 75 Hz transcranial alternating current stimulationAlso: High gamma frequency transcranial alternating current stimulationParticipants 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. | Device | Active tACS |
| sham transcranial alternating current stimulationAlso: sham tACSParticipants 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. | Device | Sham tACS |
Primary outcome
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.
2 secondary outcomes
Tolerability of electrical stimulation (pain scale)
Time frame: after each treatment session
Number of correctly retrieved words at the highest difficulty level (no supporting cues)
Time frame: during treatment sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Results publication: PubMed 30128538Fridriksson 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.
- Results publication: PubMed 28348136Nowak M, Hinson E, van Ede F, Pogosyan A, Guerra A, Quinn A, Brown P, Stagg CJ. Driving Human Motor Cortical Oscillations Leads to Behaviorally Relevant Changes in Local GABAA Inhibition: A tACS-TMS Study. J Neurosci. 2017 Apr 26;37(17):4481-4492. doi: 10.1523/JNEUROSCI.0098-17.2017. Epub 2017 Mar 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iwona Sarzyńska-Długosz principal investigator
Institute of Psychiatry and Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active 75 Hz transcranial alternating current stimulation in people with Stroke and Aphasia, run by QVITI S.A. at 1 site in Poland.
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 7 inclusion and 10 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 3 Apr 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 NCT07510464, which also lists 2 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 3 Apr 2026.