Neurostimulation for the Treatment of Post-Stroke Aphasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tACS.
- Who it may be relevant to
- Registry conditions: Post-stroke Aphasia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device tACS
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.
Primary outcome measures
- Percentage score in the Naming Task (trained words) [Time frame: 12-week follow-up]
Secondary outcome measures (12)
- Percentage score in the Naming Task (trained words) [Time frame: immediately after the intervention and 6-week follow-up]
- Number of correct answers without supporting cues [Time frame: during treatment sessions]
- Accuracy of naming during the therapy session [Time frame: during treatment sessions]
- Percentage Score in Naming Task (untrained words) [Time frame: immediately after the intervention, 6-week and 12-week follow-up]
- Communication Effectiveness Index (CETI) [Time frame: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up]
- Boston Diagnostic Aphasia Examination (BDAE) [Time frame: pre-treatment, 12-week follow-up]
- Accuracy of masking measurement: Patient and Researcher [Time frame: the end of the last treatment session]
- Visual Analog Scale (VAS) [Time frame: before and after each treatment session/during the treatment]
- Stroke and Aphasia Quality of Life Scale (SAQOL-39) Score [Time frame: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up]
- General Health Questionnaire (GHQ-12) [Time frame: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up]
- Brief Resilience Scale (BRS) [Time frame: pre-treatment, immediately after the intervention, 6-week and 12-week follow-up]
- BDNF genotype [Time frame: pre-treatment]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Think & Speak Lab at Shirley Ryan AbilityLab — Chicago
- Abilities Research Center at Mount Sinai — New York
Publications
- Fridriksson J, Elm J, Stark BC, Basilakos A, Rorden C, Sen S, George MS, Gottfried M, Bonilha L. BDNF genotype and tDCS interaction in aphasia treatment. Brain Stimul. 2018 Nov-Dec;11(6):1276-1281. doi: 10.1016/j.brs.2018.08.009. Epub 2018 Aug 18. PMID 30150003
Identifiers
NCT: NCT05194566 · STUDY-21-01577