No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
QVITI S.A. · Industry
Who this trial is looking for
This trial is looking for people who have difficulty speaking after a stroke. Participants will receive a type of brain stimulation while doing language tasks to see if it helps improve their speaking ability.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with aphasia.
I can do a naming task with 10-60% accuracy.
I had my first stroke more than 6 months ago.
I am between 18 and 80 years old.
I am right-handed.
I can give informed written consent.
I am fluent in English.
You may not be able to join if
I have severe cognitive problems that affect my ability to understand or follow commands.
I have metal implants in my skull.
I have untreated or unstable psychiatric illness.
I have a history of epilepsy or seizures.
I take medication that increases the risk of seizures.
I have a cardiac device like a pacemaker.
I had speech or hearing disabilities during childhood.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
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:
* …
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.
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