Status:
RECRUITING
Neurostimulation for the Treatment of Post-Stroke Aphasia
Lead Sponsor:
Neuro Device S.A
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Post-stroke Aphasia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 aph...
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 comm...
Eligibility Criteria
Inclusion
- 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%.
- 18-80 years
- right-handedness before the stroke.
- ability to give informed written consent.
- fluency in English.
Exclusion
- 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 stimulators or pacemaker.
- 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.
Key Trial Info
Start Date :
September 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05194566
Start Date
September 6 2023
End Date
June 1 2026
Last Update
July 8 2025
Active Locations (2)
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1
Think & Speak Lab at Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
2
Abilities Research Center at Mount Sinai
New York, New York, United States, 10029