RecruitingNot ApplicableNCT05194566
Neurostimulation for the Treatment of Post-Stroke Aphasia
Sponsor
QVITI S.A.
Enrollment
64 participants
Start Date
Sep 6, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria9
- 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.
- 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%.
- -80 years
- right-handedness before the stroke.
- ability to give informed written consent.
- fluency in English.
Exclusion Criteria15
- 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)
- 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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Interventions
DEVICEtACS
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05194566