Neurostimulation for the Treatment of Post-Stroke Aphasia
Sponsored by QVITI S.A.
About this study
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.
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 communication activities. If no improvement is observed within the first months after the stroke, a complete recovery is unlikely, and the therapy can last for years. Up to date, speech and language therapy is a standard of care for post-stroke aphasia, however the process is long and demanding. In the past, several clinical trials aimed to verify the efficacy of language training paired with transcranial direct current stimulation (tDCS), however recent meta-analysis indicates only possible effectiveness (Level C evidence) of anodal tDCS in chronic post-stroke aphasia. To boost the effects of …
Where this study is enrolling (2)
- I'm interested
Think & Speak Lab at Shirley Ryan AbilityLab
Chicago, Illinois
- I'm interested
Abilities Research Center at Mount Sinai
New York, New York
Who can participate
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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Trial data sourced from ClinicalTrials.gov.