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This study aims to investigate the efficacy of transcranial alternating current stimulation (tACS) combined with linguistic training for patients with chronic post-stroke aphasia. Thirteen patients will participate in a randomized crossover clinical trial. Their naming ability will be assessed before and after two-weeks of therapy (with 16 days of washout) supported by either 75Hz tACS or sham stimulation. The stimulated cortical area will be selected individually based on the results of functional magnetic resonance imaging.
Aphasia remains one of the most challenging long-term disabilities after stroke. Neuromodulation methods, such as transcranial electrical stimulation, may induce synaptic neuroplasticity processes and facilitate language restoration. Specifically, transcranial alternating current stimulation (tACS) may influence intrinsic cortical oscillations and GABA(A) inhibition.
This randomized, triple-blind, within-subject crossover pilot study aims to evaluate the feasibility and efficacy of tACS as an adjunct technique in the therapy of adults with chronic post-stroke aphasia.
Participants (>6 months post-stroke) will undergo 20 therapeutic sessions consisting of language training (with a focus on naming ability) combined with 75 Hz tACS over selected cortical areas. Stimulation targets will be identified individually prior to the first intervention session using functional magnetic resonance imaging (fMRI) during a naming task, selecting regions with the highest BOLD signal.
Participants will receive 10 sessions of active tACS and 10 sessions of sham stimulation in randomized order. Each intervention phase will last 2 weeks, resulting a total of 4 weeks of intervention. A 16-day washout period between the two intervention phases will be applied. The language training will include the vanishing cues method and a visual speech perception segment component to support language improvement and maintain a high level of participant motivation.
The primary outcome measure will be naming accuracy, assessed as the percentage of correctly named items in a picture-naming task (trained items), measured at three time points: immediately after completion of the intervention (last session), at 2-week, and 6-week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tACS | Experimental | Active transcranial alternating current stimulation combined with language tasks. |
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| Sham tACS | Sham Comparator | Sham transcranial alternating current stimulation combined with language tasks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active 75 Hz transcranial alternating current stimulation | Device | Participants will recive 10 sessions of active tACS. Each session includes 40 minutes (divided into 4 portions with rest breaks in between) of alternating current application in a high gamma frequency range to the language cortex via 5x5 and 5x10 (reference) electrodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage accuracy in a picture-naming task (trained items) | Naming accuracy will be assessed as the percentage of correctly named items in a naming task consisting of 40 realistic pictures of nouns that participants were unable to name correctly prior to the intervention. Score will range from 0% to 100%, where 0% indicates no correct responses and 100% indicates all items named correctly. Higher scores will indicate better naming performance. | Assessed immediately after completion of the intervention (last session), at 2-week, and 6-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of electrical stimulation (pain scale) | Pain intensity will be measured using the Wong-Baker FACES Pain Rating Scale, a validated visual analogue scale ranging from 0 to 10, where 0 indicates "no hurt" and 10 indicates "hurts worst". Higher scores will indicate greater pain intensity, reflect worse tolerability of stimulation. | after each treatment session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iwona Sarzyńska-Długosz | Institute of Psychiatry and Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Projekt Samodzielni" sp. z o.o. | Warsaw | Masovian Voivodeship | 02-366 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30128538 | Result | Fridriksson J, Rorden C, Elm J, Sen S, George MS, Bonilha L. Transcranial Direct Current Stimulation vs Sham Stimulation to Treat Aphasia After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1470-1476. doi: 10.1001/jamaneurol.2018.2287. | |
| 28348136 | Result | Nowak M, Hinson E, van Ede F, Pogosyan A, Guerra A, Quinn A, Brown P, Stagg CJ. Driving Human Motor Cortical Oscillations Leads to Behaviorally Relevant Changes in Local GABAA Inhibition: A tACS-TMS Study. J Neurosci. 2017 Apr 26;37(17):4481-4492. doi: 10.1523/JNEUROSCI.0098-17.2017. Epub 2017 Mar 27. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| sham transcranial alternating current stimulation | Device | Participants will recive 10 sessions of sham stimulation. Each session mimics tha active condition, with brief fade-in and fade-out periods (30 seconds) at the beginning and end of each stimulation portion, without delivering a therapeutic dose. Stimualtion is applied over the left hemisphere via 5x5 and 5x10 (reference) electrodes. |
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| Number of correctly retrieved words at the highest difficulty level (no supporting cues) | Naming efficacy will be assessed as the absolute number of correctly retrieved words at the highest difficulty level of the anomia treatment task paired with 75 Hz tACS or sham stimulation. At this level, the target object will be presented without any supporting cues. Higher score will present a better naming performance. | during treatment sessions |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |