NCT07510464

Transcranial Alternating Current Stimulation in Post Stroke Aphasia Therapy

Transcranial Alternating Current Stimulation in Post Stroke Aphasia Therapy. A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: QVITI S.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stroke
• Aphasia

Interventions

Type	Name	Description
DEVICE	active 75 Hz transcranial alternating current stimulation	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.
DEVICE	sham transcranial alternating current stimulation	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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Poland