Post-stroke AphasiaNCT05194566
Neurostimulation for the Treatment of Post-Stroke Aphasia
A study testing tACS in people with Post-stroke Aphasia, run by QVITI S.A. at 2 sites in United States.
Trial summary
The aim of the trial is to determine whether 75Hz transcranial alternating current stimulation (tACS) synchronized with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-stroke Aphasia
- What is being tested?
- tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Sep 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist).
- presence of a focus of injury in the left hemisphere (within one hemisphere only) as a result of the first ischemic or hemorrhagic stroke (based on CT/MRI examination);
- chronic stage of the disease - time since the stroke occurred over 6 months.
- ability to achieve an accuracy in the Naming Task of 10-60%.
- 18-80 years
- right-handedness before the stroke.
- ability to give informed written consent.
- fluency in English.
Who cannot join
- severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command.
- presence of metal implants in the skull.
- presence of major untreated or unstable psychiatric disease.
- history of epilepsy or seizures.
- ongoing medication that increases the risk of epileptic seizures.
- presence in the body of cardiac stimulator, pacemaker or vagus nerve stimulator (implanted).
Show all 15Show fewer
- history of speech, language, hearing, or intellectual disability during childhood.
- pregnancy (based on declarations)
- high intolerance to stimulation.
- occurrence of an epileptic seizure.
- other previously absent neurological or mental symptoms
- Withdrawal criteria:
- high intolerance to stimulation (participants experience severe discomfort during stimulation);
- occurrence of an epileptic seizure;
- other previously absent neurological, physical or mental symptoms.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Think & Speak Lab at Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Tertia Jeppson, M.A., CCC-SLP, CBIS, 312-238-6163, tjeppson@sralab.org
Leora Cherney, PhD, CCC-SLP, BC-ANCDS, FACRM
- Recruiting
Abilities Research Center at Mount Sinai
New York, New York, 10029
Raphael Kesselman, 917-886-4668, raphael.kesselman@mountsinai.org
Aidan Rogers, (718) 308-9450, aidan.rogers@mountsinai.org
About this study
The aim of the trial is to determine whether 75Hz transcranial alternating current stimulation (tACS) synchronized with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia.
Read the detailed description
There are about 15 million strokes worldwide each year. Of this group, about 30% suffer from aphasia. Aphasia is a speech-language disorder associated with exceptional difficulty performing daily communication activities. If no improvement is observed within the first months after the stroke, a complete recovery is unlikely, and the therapy can last for years.
Up to date, speech and language therapy is a standard of care for post-stroke aphasia, however the process is long and demanding.
In the past, several clinical trials aimed to verify the efficacy of language training paired with transcranial direct current stimulation (tDCS), however recent meta-analysis indicates only possible effectiveness (Level C evidence) of anodal tDCS in chronic post-stroke aphasia.
To boost the effects of aphasia rehabilitation, effective brain stimulation protocol still needs to be developed.
Transcranial alternating current stimulation (tACS) can be an interesting alternative to tDCS, as it is able to influence cortical excitability and activity.
Stimulation within high gamma oscillations (60-500Hz) might allow for better speech-language processing, as this band is considered to be the cognitive index of linguistic processes. Moreover, a short period of 75Hz tACS over the motor cortex suggested the positive impact of high-gamma tACS on brain plasticity.
The aim of this RCT is to determine whether 75Hz transcranial alternating current stimulation (tACS) paired with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia, measured as an ability to name trained items at 12 weeks follow-up.
- Conditions
- Post-stroke Aphasia
- Being tested
- tACS
- Keywords
- speech therapy, brain stimulation, communication, language
- Medical subject headings
- Communication Disorders, Communication, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACSDevice
Also called transcranial alternating current stimulation
Neurostimulation will be done using the Neuro Device tCS, which is a certified transcranial electrical stimulator. The device consists of a stimulator with a touch screen, two electrodes and a soft, flexible cap to ensure stability of the electrodes on the head.
| Study group | Role | What they receive |
|---|---|---|
| Real tACS | Active comparator | tACS 75Hz intervention combined with language tasks and breathing exercises. The device will operate in tACS research active stimulation mode. Receives: Device: tACS |
| Sham tACS | Sham comparator | tACS sham intervention combined with language tasks and breathing exercises. The device will operate in tACS sham simulation research mode. Receives: Device: tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage score in the Naming Task (trained words)
The Baseline Naming Task consists of 344 images representing nouns and the images will be presented on the computer screen. The task is to name the presented noun by producing the name of the item out loud. The answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items marked with a score of 3 are considered accurate. From the baseline assessment, a random list of 50 incorrectly named words will be trained in therapy. Minimum score is 0% (inability to name any objects) and maximum score is 100% (accuracy in naming all presented objects), where a higher score indicates a better health outcome
Measured: 12-week follow-up
Secondary outcomes (12)
Percentage score in the Naming Task (trained words)
The Baseline Naming Task consists of 344 images representing nouns and the images will be presented on the computer screen. The task is to name the presented noun by producing the name of the item out loud. The answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items marked with a score of 3 are considered accurate. From the baseline assessment, a random list of 50 incorrectly named words will be trained in therapy. Minimum score is 0% (inability to name any objects) and maximum score is 100% (accuracy in naming all presented objects), where a higher score indicates a better health outcome
Measured: immediately after the intervention and 6-week follow-up
Number of correct answers without supporting cues
Number of correct answers on the fifth level (no cueing) during the therapy task. Greater number of correct responses indicates better response to treatment.
Measured: during treatment sessions
Accuracy of naming during the therapy session
Number of correct responses to presented stimuli. Greater number of correct responses indicates better response to treatment.
Measured: during treatment sessions
Percentage Score in Naming Task (untrained words)
Percentage score calculated for words not trained in therapy task to assess generalization. Patients are presented with 25 words not trained during therapy sessions. Each answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items receiving a score of 3 are marked as correct, with a maximum total number of correct items being 25. Minimum score is 0% (0/25- inability to name any objects) and maximum score is 100% (25/25- accuracy in naming all presented objects), where higher score indicates better response to treatment.
Measured: immediately after the intervention, 6-week and 12-week follow-up
Communication Effectiveness Index (CETI)
The participants primary communication partner rates the participants' ability to perform in sixteen communication situations on a visual analog scale with the lowest value (a score of 0) as "not at all able" and the greatest value (a score of 10) as "as able to as before", where higher scores indicate better health outcomes.
Measured: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up
Boston Diagnostic Aphasia Examination (BDAE)
Oral Expression Subtest - the speech language pathologist assesses the patient with the oral expression portion of the BDAE. Areas assessed include automatic sequences, repetition of words and sentences, responsive and confrontational naming, and screening of letters and numbers. Each item receives a point for correctness with a maximal score of 48
Measured: pre-treatment, 12-week follow-up
Accuracy of masking measurement: Patient and Researcher
The opinion of the patient and of the researcher on receiving the placebo vs. active stimulation. The patient and researcher provide their guess/opinion as to whether the stimulation received during treatment was active or sham. It will be taken after the end of the last treatment session.
Measured: the end of the last treatment session
Visual Analog Scale (VAS)
Stimulation tolerance/side effects are measured using a visual analog scale with seven components (headache, fatigue, sleepiness, dizziness, pain on scalp, tingling on scalp, burning sensation on scalp, and itching on scalp). Ratings will be taken before and after each session. Full scale 0-10 per component. Higher score indicates a higher degree of each side effect.
Measured: before and after each treatment session/during the treatment
Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score
Assesses the ability to complete daily tasks pertaining to self-care, communication, interaction with others, and physical mobility. The SAQOL includes 17 questions, where questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Total score ranges from 17-85. Scores are averaged across three domains (physical, communication, and psychosocial), with lower scores indicating lesser ability (lower quality of life) and higher scores indicating great ability or independence (greater quality of life)
Measured: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up
General Health Questionnaire (GHQ-12)
Identifies minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients. GHQ-12 is a 12-items scaled version that assesses somatic symptoms, anxiety, and insomnia, social dysfunction, and severe depression. A total score ranges from 0 to 36, with higher scores indicating worse conditions
Measured: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up
Brief Resilience Scale (BRS)
Assesses the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience). Higher scores indicate better health outcomes.
Measured: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up
BDNF genotype
Saliva samples will be collected to test for typical vs. atypical brain plasticity biomarkers, as BDNF genotype may interfere with results of therapy paired with transcranial electrical stimulation. Research suggests that individuals with an atypical BDNF genotype are less receptive to the beneficial effects of speech-language therapy paired with anodal transcranial direct current stimulation, compared to individuals with typical BDNF genotype
Measured: pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start6 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke AphasiaStudies 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
- Parallel groups
- Model description
- The study will employ a between-subject randomized sham-controlled design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QVITI S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Miguel Escalon, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194566
- Sponsor's protocol ID
- STUDY-21-01577
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2022
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not applicable to study aims
Publications
Fridriksson J, Elm J, Stark BC, Basilakos A, Rorden C, Sen S, George MS, Gottfried M, Bonilha L. BDNF genotype and tDCS interaction in aphasia treatment. Brain Stimul. 2018 Nov-Dec;11(6):1276-1281. doi: 10.1016/j.brs.2018.08.009. Epub 2018 Aug 18.
PubMed 30150003
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation for the Treatment of Post-Stroke Aphasia
- ClinicalTrials.gov ID
- NCT05194566
- Acronym / sponsor ID
- STUDY-21-01577
- Conditions
- Post-stroke Aphasia
- Keywords
- speech therapy, brain stimulation, communication, language
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- QVITI S.A.Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jan 2022 (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.
The aim of the trial is to determine whether 75Hz transcranial alternating current stimulation (tACS) synchronized with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia.
Detailed description
There are about 15 million strokes worldwide each year. Of this group, about 30% suffer from aphasia. Aphasia is a speech-language disorder associated with exceptional difficulty performing daily communication activities. If no improvement is observed within the first months after the stroke, a complete recovery is unlikely, and the therapy can last for years.
Up to date, speech and language therapy is a standard of care for post-stroke aphasia, however the process is long and demanding.
In the past, several clinical trials aimed to verify the efficacy of language training paired with transcranial direct current stimulation (tDCS), however recent meta-analysis indicates only possible effectiveness (Level C evidence) of anodal tDCS in chronic post-stroke aphasia.
To boost the effects of aphasia rehabilitation, effective brain stimulation protocol still needs to be developed.
Transcranial alternating current stimulation (tACS) can be an interesting alternative to tDCS, as it is able to influence cortical excitability and activity.
Stimulation within high gamma oscillations (60-500Hz) might allow for better speech-language processing, as this band is considered to be the cognitive index of linguistic processes. Moreover, a short period of 75Hz tACS over the motor cortex suggested the positive impact of high-gamma tACS on brain plasticity.
The aim of this RCT is to determine whether 75Hz transcranial alternating current stimulation (tACS) paired with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia, measured as an ability to name trained items at 12 weeks follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will employ a between-subject randomized sham-controlled design.
| Arm | Type | Receives |
|---|---|---|
| Real tACS | Active comparator | Device: tACStACS 75Hz intervention combined with language tasks and breathing exercises. The device will operate in tACS research active stimulation mode. |
| Sham tACS | Sham comparator | Device: tACStACS sham intervention combined with language tasks and breathing exercises. The device will operate in tACS sham simulation research mode. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist).
- presence of a focus of injury in the left hemisphere (within one hemisphere only) as a result of the first ischemic or hemorrhagic stroke (based on CT/MRI examination);
- chronic stage of the disease - time since the stroke occurred over 6 months.
- ability to achieve an accuracy in the Naming Task of 10-60%.
- 18-80 years
Key exclusion criteria (15 listed)
- severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command.
- presence of metal implants in the skull.
- presence of major untreated or unstable psychiatric disease.
- history of epilepsy or seizures.
- ongoing medication that increases the risk of epileptic seizures.
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 |
|---|---|---|
| tACSAlso: transcranial alternating current stimulationNeurostimulation will be done using the Neuro Device tCS, which is a certified transcranial electrical stimulator. The device consists of a stimulator with a touch screen, two electrodes and a soft, flexible cap to ensure stability of the electrodes on the head. | Device | Real tACS, Sham tACS |
Primary outcome
Percentage score in the Naming Task (trained words)
Time frame: 12-week follow-up
The Baseline Naming Task consists of 344 images representing nouns and the images will be presented on the computer screen. The task is to name the presented noun by producing the name of the item out loud. The answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items marked with a score of 3 are considered accurate. From the baseline assessment, a random list of 50 incorrectly named words will be trained in therapy. Minimum score is 0% (inability to name any objects) and maximum score is 100% (accuracy in naming all presented objects), where a higher score indicates a better health outcome
12 secondary outcomes
Percentage score in the Naming Task (trained words)
Time frame: immediately after the intervention and 6-week follow-up
Number of correct answers without supporting cues
Time frame: during treatment sessions
Accuracy of naming during the therapy session
Time frame: during treatment sessions
Percentage Score in Naming Task (untrained words)
Time frame: immediately after the intervention, 6-week and 12-week follow-up
Communication Effectiveness Index (CETI)
Time frame: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up
Boston Diagnostic Aphasia Examination (BDAE)
Time frame: pre-treatment, 12-week follow-up
Accuracy of masking measurement: Patient and Researcher
Time frame: the end of the last treatment session
Visual Analog Scale (VAS)
Time frame: before and after each treatment session/during the treatment
Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score
Time frame: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up
General Health Questionnaire (GHQ-12)
Time frame: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up
Brief Resilience Scale (BRS)
Time frame: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up
BDNF genotype
Time frame: pre-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 30150003Fridriksson J, Elm J, Stark BC, Basilakos A, Rorden C, Sen S, George MS, Gottfried M, Bonilha L. BDNF genotype and tDCS interaction in aphasia treatment. Brain Stimul. 2018 Nov-Dec;11(6):1276-1281. doi: 10.1016/j.brs.2018.08.009. Epub 2018 Aug 18.
- Individual participant dataSharing planned: No. Not applicable to study aims
Related trials for Post-stroke Aphasia
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Recruiting
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
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Recruiting
Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
Aphasia Non Fluent, Stroke
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.
Miguel Escalon, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS in people with Post-stroke Aphasia, run by QVITI S.A. at 2 sites 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 8 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tertia Jeppson (312-238-6163, tjeppson@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage score in the Naming Task (trained words) (time frame: 12-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 NCT05194566, which also lists 1 linked publication.
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 18 Feb 2026.