Ireland
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Recruiting Not applicable

Neurostimulation for the Treatment of Post-Stroke Aphasia

NCT05194566 · tracked via the Priya Life Science USA tracker
Sponsor
QVITI S.A
Phase
Not applicable
Started
2023-09-06
Last updated
2026-02-18

Condition(s) studied

Post-stroke Aphasia

Investigational drug(s) / intervention(s)

tACS

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Individuals with aphasia (assessed using the Boston Diagnostic Aphasia Examination) who perform the Naming Task in the range of 10%-60% accuracy will be included in the study. The overall baseline score in the Naming Task will be estimated from the two baseline measurements. 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.

Primary outcome measure(s)

  • Percentage score in the Naming Task (trained words) — 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

Trial sites (2)

FacilityCityRegionStatus
Think & Speak Lab at Shirley Ryan AbilityLab Chicago Illinois Recruiting
Abilities Research Center at Mount Sinai New York New York Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05194566 on ClinicalTrials.gov ↗ ← All trials in the USA