Neurostimulation for the Treatment of Post-Stroke Aphasia
Overview
- Phase
- Not Applicable
- Intervention
- tACS
- Conditions
- Post-stroke Aphasia
- Sponsor
- QVITI S.A.
- Enrollment
- 64
- Locations
- 3
- Primary Endpoint
- Percentage score in the Naming Task (trained words)
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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 aphasia.
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 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 aphasia rehabilitation, effective brain stimulation protocol still needs to be developed. Transcranial alternating current stimulation (tACS) can be an interesting alternative to tDCS, as it is able to influence cortical excitability and activity. Stimulation within high gamma oscillations (60-500Hz) might allow for better speech-language processing, as this band is considered to be the cognitive index of linguistic processes. Moreover, a short period of 75Hz tACS over the motor cortex suggested the positive impact of high-gamma tACS on brain plasticity. The aim of this RCT is to determine whether 75Hz transcranial alternating current stimulation (tACS) paired with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia, measured as an ability to name trained items at 12 weeks follow-up.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Real tACS
tACS 75Hz intervention combined with language tasks and breathing exercises. The device will operate in tACS research active stimulation mode.
Intervention: tACS
Sham tACS
tACS sham intervention combined with language tasks and breathing exercises. The device will operate in tACS sham simulation research mode.
Intervention: tACS
Outcomes
Primary Outcomes
Percentage score in the Naming Task (trained words)
Time Frame: 12-week follow-up
The Baseline Naming Task consists of 344 images representing nouns and the images will be presented on the computer screen. The task is to name the presented noun by producing the name of the item out loud. The answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items marked with a score of 3 are considered accurate. From the baseline assessment, a random list of 50 incorrectly named words will be trained in therapy. Minimum score is 0% (inability to name any objects) and maximum score is 100% (accuracy in naming all presented objects), where a higher score indicates a better health outcome
Secondary Outcomes
- Percentage score in the Naming Task (trained words)(immediately after the intervention and 6-week follow-up)
- Number of correct answers without supporting cues(during treatment sessions)
- Accuracy of naming during the therapy session(during treatment sessions)
- Percentage Score in Naming Task (untrained words)(immediately after the intervention, 6-week and 12-week follow-up)
- Communication Effectiveness Index (CETI)(pre-treatment, immediately after the intervention, 6-week and 12-week follow-up)
- Boston Diagnostic Aphasia Examination (BDAE)(pre-treatment, 12-week follow-up)
- Accuracy of masking measurement: Patient and Researcher(the end of the last treatment session)
- Visual Analog Scale (VAS)(before and after each treatment session/during the treatment)
- Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score(pre-treatment, immediately after the intervention, 6-week and 12-week follow-up)
- General Health Questionnaire (GHQ-12)(pre-treatment, immediately after the intervention, 6-week and 12-week follow-up)
- Brief Resilience Scale (BRS)(pre-treatment, immediately after the intervention, 6-week and 12-week follow-up)
- BDNF genotype(pre-treatment)