Post-stroke Aphasia
Conditions
Keywords
speech therapy, brain stimulation, communication, language
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.
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.
Sponsors
QVITI S.A.
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participant, investigator and outcomes assessor are all blinded. Designated research team members will be unblinded in order to manage computerized procedure.
Intervention model description
The study will employ a between-subject randomized sham-controlled design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage score in the Naming Task (trained words) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage score in the Naming Task (trained words) | immediately after the intervention and 6-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 |
| Number of correct answers without supporting cues | during treatment sessions | Number of correct answers on the fifth level (no cueing) during the therapy task. Greater number of correct responses indicates better response to treatment. |
| Accuracy of naming during the therapy session | during treatment sessions | Number of correct responses to presented stimuli. Greater number of correct responses indicates better response to treatment. |
| Percentage Score in Naming Task (untrained words) | immediately after the intervention, 6-week and 12-week follow-up | Percentage score calculated for words not trained in therapy task to assess generalization. Patients are presented with 25 words not trained during therapy sessions. Each answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items receiving a score of 3 are marked as correct, with a maximum total number of correct items being 25. Minimum score is 0% (0/25- inability to name any objects) and maximum score is 100% (25/25- accuracy in naming all presented objects), where higher score indicates better response to treatment. |
| Communication Effectiveness Index (CETI) | pre-treatment, immediately after the intervention, 6-week and 12-week follow-up | The participants primary communication partner rates the participants' ability to perform in sixteen communication situations on a visual analog scale with the lowest value (a score of 0) as "not at all able" and the greatest value (a score of 10) as "as able to as before", where higher scores indicate better health outcomes. |
| Boston Diagnostic Aphasia Examination (BDAE) | pre-treatment, 12-week follow-up | Oral Expression Subtest - the speech language pathologist assesses the patient with the oral expression portion of the BDAE. Areas assessed include automatic sequences, repetition of words and sentences, responsive and confrontational naming, and screening of letters and numbers. Each item receives a point for correctness with a maximal score of 48 |
| Accuracy of masking measurement: Patient and Researcher | the end of the last treatment session | The opinion of the patient and of the researcher on receiving the placebo vs. active stimulation. The patient and researcher provide their guess/opinion as to whether the stimulation received during treatment was active or sham. It will be taken after the end of the last treatment session. |
| Visual Analog Scale (VAS) | before and after each treatment session/during the treatment | Stimulation tolerance/side effects are measured using a visual analog scale with seven components (headache, fatigue, sleepiness, dizziness, pain on scalp, tingling on scalp, burning sensation on scalp, and itching on scalp). Ratings will be taken before and after each session. Full scale 0-10 per component. Higher score indicates a higher degree of each side effect. |
| Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score | pre-treatment, immediately after the intervention, 6-week and 12-week follow-up | Assesses the ability to complete daily tasks pertaining to self-care, communication, interaction with others, and physical mobility. The SAQOL includes 17 questions, where questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Total score ranges from 17-85. Scores are averaged across three domains (physical, communication, and psychosocial), with lower scores indicating lesser ability (lower quality of life) and higher scores indicating great ability or independence (greater quality of life) |
| General Health Questionnaire (GHQ-12) | pre-treatment, immediately after the intervention, 6-week and 12-week follow-up | Identifies minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients. GHQ-12 is a 12-items scaled version that assesses somatic symptoms, anxiety, and insomnia, social dysfunction, and severe depression. A total score ranges from 0 to 36, with higher scores indicating worse conditions |
| Brief Resilience Scale (BRS) | pre-treatment, immediately after the intervention, 6-week and 12-week follow-up | Assesses the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience). Higher scores indicate better health outcomes. |
| BDNF genotype | pre-treatment | Saliva samples will be collected to test for typical vs. atypical brain plasticity biomarkers, as BDNF genotype may interfere with results of therapy paired with transcranial electrical stimulation. Research suggests that individuals with an atypical BDNF genotype are less receptive to the beneficial effects of speech-language therapy paired with anodal transcranial direct current stimulation, compared to individuals with typical BDNF genotype |
Countries
United States
Contacts
CONTACTTertia Jeppson
CONTACTAidan Rogers
PRINCIPAL_INVESTIGATORMiguel Escalon, MD, MPH
Icahn School of Medicine at Mount Sinai
Outcome results
None listed