NCT05194566 · QVITI S.A.
Neurostimulation for the Treatment of Post-Stroke Aphasia
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
tACS
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
- history of speech, language, hearing, or intellectual disability during childhood.
- pregnancy (based on declarations) Exclusion criteria during the trial:
- 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.
Where
- Chicago, Illinois
- New York, New York
Collaborators
Icahn School of Medicine at Mount Sinai
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations