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AphasiaNCT04375722

Transcranial Alternating Current Stimulation (tACS) in Aphasia

A study testing tACS in people with Aphasia and Stroke, run by Medical College of Wisconsin at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke as well as healthy language functions. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Aphasia, Stroke
What is being tested?
tACS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
4 Jan 2020to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy Controls
  • 18 years of age or older
  • Fluent in English
  • No history of neurological or psychiatric disorders
  • Stroke Patients
  • Diagnosed with post-stroke aphasia by referring physician/neuropsychologist
Show all 10Show fewer
  • Consent date >=1 months after stroke onset
  • Right-handed
  • Fluent in English
  • 18 years of age or older

Who cannot join

  • Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
  • Presence of major untreated or unstable psychiatric disease
  • A chronic medical condition that is not treated or is unstable
  • The presence of cardiac stimulators or pacemakers
  • Any metal implants in the skull
  • Contraindications to MRI or tACS
  • History of seizures
  • History of dyslexia or other developmental learning disabilities

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Sidney Schoenrock, MA, 414-955-7579, sschoenrock@mcw.edu

    Recruiting

Other trials in United States

About this study

Official title: Exogenous Tuning of Neural Oscillations as a Mode of Treatment in Post-stroke Aphasia

This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke as well as healthy language functions.

Read the detailed description

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 (NIH-NIDCD, 2015). 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 by providing 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 aphasia. TACS differs from widely used transcranial direct current stimulation (tDCS) in that sinusoidal, alternating currents are delivered rather than constant currents. TACS can manipulate the ongoing oscillatory neuronal activity and potentially increase functional synchronization (or connectivity) between targeted areas. This feature of tACS is quite attractive, given the new body of evidence suggesting that language impairments stem from diminished functional connectivity and disruptions in the language network due to stroke. The selection of tACS frequencies in this study is guided by our preliminary work examining pathological neural oscillations found near stroke-lesioned areas (or perilesional) in aphasia and by the involvement of specific frequencies during a verbal short-term memory task. By exogenously tuning the neural oscillations with tACS, the investigators hope to up-regulate communication across regions within the language network and other connected areas to improve outcomes. If successful, tACS will be a powerful and novel treatment approach with reverberating positive impact on long-term recovery.

The study will employ HD-tACS in a within-subject and sham-controlled design, using frequencies ranging from theta to low-gamma (4-40 Hz) combined with language tasks. Magnetoencephalography (MEG) or electroencephalography (EEG) will be used to determine tACS frequencies and to evaluate behavioral and neurophysiological changes in response to tACS. Investigators plan to recruit 200 participants: 100 stroke survivors with aphasia and 100 healthy controls.

Participants will complete language testing that covers a broad range of language functions, medical history, and MRI. Eligible participants will undergo active tACS or sham-tACS over 3-4 sessions. The tACS administrator and participants will be blinded to the stimulation type. The order of stimulation type will be counterbalanced across participants. Washout period between visits will be at least 48 hours to minimize potential carryover effects. MEG will be collected prior to tACS sessions during a language task to determine tACS frequency. EEG may be acquired before and after tACS during periods of rest (resting-state) and during language tasks. Participants will complete a questionnaire at the end of stimulation visits to assess potential side effects of tACS. Total time enrolled in the study is expected to be 2-3 weeks, which may be longer depending on participant's availability.

Conditions
Aphasia, Stroke
Being tested
tACS
Keywords
language, language impairment, transcranial alternating current stimulation, tACS
Medical subject headings
Aphasia, Stroke, Language, Language Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tACSDevice

    Active or Sham tACS will be applied.

Study groups in NCT04375722
Study groupRoleWhat they receive
tACS low frequencyExperimentalAll participants in a within-subject design will receive high-Definition-tACS, delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system or fMRI-guided targets with center electrodes placed at a frontal/anterior and a temporoparietal/posterior site. The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS with frequencies ranging from 4-40Hz for 20-minutes with 2 milliampere (mA) peak-to-peak intensity. For sham stimulation, tACS is turned off after the first 30 seconds.
Receives: Device: tACS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tACS changes in language performance verbal STM tasks

    Improvement on verbal STM performance as determined by increases in span, accuracy or decreases in reaction time is expected with active tACS.

    Measured: Changes monitored over pre, during and immediately after 20 minutes of tACS

  2. tACS-dependent neurophysiological changes

    Concomitant frequency-specific EEG changes in spectral power and phase synchronization are expected.

    Measured: Changes monitored over pre and immediately after 20 minutes of tACS

Secondary outcomes (1)
  1. Individual differences in tACS responsiveness

    tACS responsiveness depending on language impairment types, stroke lesion and language lateralization characteristics will be explored.

    Measured: Based on immediate changes monitored after 20 minutes of tACS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2020
  2. Study start4 Jan 2020
  3. Primary completionJan 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
In the within-subject design healthy participants and stroke survivors will receive tACS stimulation with active and/or sham settings in a randomized order with \>48 hours washout period in between stimulation sessions.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04375722
Sponsor's protocol ID
36878
Status last verified
Jul 2026
First submitted
1 May 2020
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.

    PubMed 28709880
  • Bucur M, Papagno C. Are transcranial brain stimulation effects long-lasting in post-stroke aphasia? A comparative systematic review and meta-analysis on naming performance. Neurosci Biobehav Rev. 2019 Jul;102:264-289. doi: 10.1016/j.neubiorev.2019.04.019. Epub 2019 May 8.

    PubMed 31077693
  • Buzsaki, G. (2006). Rhythms of the brain. New York: Oxford.

  • Chu RK, Braun AR, Meltzer JA. MEG-based detection and localization of perilesional dysfunction in chronic stroke. Neuroimage Clin. 2015 Apr 8;8:157-69. doi: 10.1016/j.nicl.2015.03.019. eCollection 2015.

    PubMed 26106540
  • Dubovik S, Ptak R, Aboulafia T, Magnin C, Gillabert N, Allet L, Pignat JM, Schnider A, Guggisberg AG. EEG alpha band synchrony predicts cognitive and motor performance in patients with ischemic stroke. Behav Neurol. 2013;26(3):187-9. doi: 10.3233/BEN-2012-129007.

    PubMed 22713421
  • Finnigan S, van Putten MJ. EEG in ischaemic stroke: quantitative EEG can uniquely inform (sub-)acute prognoses and clinical management. Clin Neurophysiol. 2013 Jan;124(1):10-9. doi: 10.1016/j.clinph.2012.07.003. Epub 2012 Aug 2.

    PubMed 22858178
  • Finnigan SP, Walsh M, Rose SE, Chalk JB. Quantitative EEG indices of sub-acute ischaemic stroke correlate with clinical outcomes. Clin Neurophysiol. 2007 Nov;118(11):2525-32. doi: 10.1016/j.clinph.2007.07.021. Epub 2007 Sep 21.

    PubMed 17889600
  • 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.

    PubMed 30128538
  • Fries P. Rhythms for Cognition: Communication through Coherence. Neuron. 2015 Oct 7;88(1):220-35. doi: 10.1016/j.neuron.2015.09.034.

    PubMed 26447583
  • Grefkes C, Fink GR. Reorganization of cerebral networks after stroke: new insights from neuroimaging with connectivity approaches. Brain. 2011 May;134(Pt 5):1264-76. doi: 10.1093/brain/awr033. Epub 2011 Mar 16.

    PubMed 21414995
  • Helfrich RF, Schneider TR, Rach S, Trautmann-Lengsfeld SA, Engel AK, Herrmann CS. Entrainment of brain oscillations by transcranial alternating current stimulation. Curr Biol. 2014 Feb 3;24(3):333-9. doi: 10.1016/j.cub.2013.12.041. Epub 2014 Jan 23.

    PubMed 24461998
  • Herrmann CS, Rach S, Neuling T, Struber D. Transcranial alternating current stimulation: a review of the underlying mechanisms and modulation of cognitive processes. Front Hum Neurosci. 2013 Jun 14;7:279. doi: 10.3389/fnhum.2013.00279. eCollection 2013.

    PubMed 23785325
  • Kielar A, Deschamps T, Chu RK, Jokel R, Khatamian YB, Chen JJ, Meltzer JA. Identifying Dysfunctional Cortex: Dissociable Effects of Stroke and Aging on Resting State Dynamics in MEG and fMRI. Front Aging Neurosci. 2016 Mar 3;8:40. doi: 10.3389/fnagi.2016.00040. eCollection 2016.

    PubMed 26973515
  • Shah-Basak PP, Wurzman R, Purcell JB, Gervits F, Hamilton R. Fields or flows? A comparative metaanalysis of transcranial magnetic and direct current stimulation to treat post-stroke aphasia. Restor Neurol Neurosci. 2016 May 2;34(4):537-58. doi: 10.3233/RNN-150616.

    PubMed 27163249
  • Shah-Basak PP, Kielar A, Deschamps T, Verhoeff NP, Jokel R, Meltzer J. Spontaneous oscillatory markers of cognitive status in two forms of dementia. Hum Brain Mapp. 2019 Apr 1;40(5):1594-1607. doi: 10.1002/hbm.24470. Epub 2018 Nov 12.

    PubMed 30421472

Questions about this trial

What is this clinical trial studying?

A study testing tACS in people with Aphasia and Stroke, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sidney Schoenrock, MA (414-955-7579 ext. 4149557579, sschoenrock@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tACS changes in language performance verbal STM tasks (time frame: Changes monitored over pre, during and immediately after 20 minutes of tACS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04375722, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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