Neurostimulation for the Treatment of Post-Stroke Aphasia

Launched by NEURO DEVICE S.A · Jan 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new therapy for people who have difficulty speaking after a stroke, a condition known as post-stroke aphasia. The researchers want to see if a treatment called 75Hz transcranial alternating current stimulation (tACS) can help improve language skills when used alongside specific language tasks. They are currently looking for participants aged 18 to 80 who have been diagnosed with aphasia and can achieve a naming accuracy of 10-60% on a standard test. This study is open to individuals who are right-handed and fluent in English, as long as they meet certain health criteria.

If you decide to participate, you can expect to receive this stimulation treatment while working on language tasks in a supportive environment. Before starting, your eligibility will be checked to ensure you meet the necessary guidelines. It’s important to note that some people may not qualify for the trial due to conditions like severe cognitive issues, certain medical implants, or a history of seizures. Participants will be closely monitored throughout the study for any discomfort or unexpected health issues. This trial provides a potential new way to improve communication skills for those affected by stroke-related language difficulties.

Gender

ALL

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:
• • 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 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.