An interventional study of HD-tACS and Sham HD-tACS in Stroke and Aphasia, sponsored by Medical College of Wisconsin. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke.
Aphasia is a debilitating disorder, typically resulting from damage to the left hemisphere, that can impair a range of communication abilities, including language production and comprehension, reading, and writing. Approximately 180,000 new cases of aphasia are identified per year, and approximately 1 million or 1 in 250 are living with aphasia in the United States. Treatments are limited and provide modest benefits at best. The current emphasis in aphasia rehabilitation is to formulate intensive speech and language therapies and augment therapeutic benefits, potentially with brain stimulation concurrent with therapies.
The current study will investigate the efficacy of high-definition tACS (HD-tACS) to help restore neural oscillatory activity in stroke survivors with aphasia. TACS differs from trancranial direct current stimulation (tDCS), a widely used brain stimulation paradigm, in that sinusoidal or alternating currents are delivered rather than direct currents. TACS is shown to manipulate ongoing oscillatory brain activity and also to modulate synchronization (or connectivity) between targeted brain areas. This feature of tACS is quite attractive, given the new body of evidence suggesting that language impairments stem from diminished brain connectivity and ensuing disruptions in the language network due to stroke.
The study will employ high-definition tACS (HD-tACS) in a parallel, double-blinded, sham-controlled design combined with language therapy targeting phonological short-term memory (STM) function in stroke survivors with aphasia. Magnetoencephalography (MEG) and fMRI BOLD data collection will occur to determine tACS parameters and to evaluate stimulation-induced neural changes, respectively. The investigators plan to recruit 120 stroke survivors with aphasia in a 2-group tACS study design.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 120 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
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Exclusion Criteria:
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High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages.The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS stimulation for 20-minutes with 2 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes. This will be paired with short-term memory focused speech therapy.
Device: HD-tACS
High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the active tACS groups. This will be paired with short-term memory focused speech therapy.
Device: Sham HD-tACS
High definition tACS will be applied during speech therapy.
Sham high definition tACS will be applied during speech therapy.
Accuracy on a phonological STM task
Accuracy changes in a delayed sample-to-match task assessing phonological STM after tACS.
Time frame: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
fMRI measures of language network activation after tACS
Activation in the language network regions involved in phonological STM will be assessed before and after tACS
Time frame: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
Functional Communication Outcome
Improvements in using language in daily life or functional communication as assessed by patient reported measure of Communication Effectiveness Index (CETI)
Time frame: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
Plan to share: No
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