Transcranial Alternating Current Stimulation (tACS) in Aphasia

NCT04375722 | Recruiting FDA Device

• 1 other identifier: 36878
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aphasia; Stroke

Keywords

language; language impairment; transcranial alternating current stimulation; tACS

Outcome Measures

Primary Outcomes (2)

• 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.

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

• tACS-dependent neurophysiological changes

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

  Changes monitored over pre and immediately after 20 minutes of tACS

Secondary Outcomes (1)

• Individual differences in tACS responsiveness

  Based on immediate changes monitored after 20 minutes of tACS

Study Arms (1)

tACS 10 Hz low frequency

EXPERIMENTAL

All 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 with center electrodes placed at a frontal and a temporoparietal 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.

Device: tACS

Interventions

tACS DEVICE

Active or Sham tACS will be applied.

tACS 10 Hz low frequency

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Controls
• 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
• Consent date \>=1 months after stroke onset
• Right-handed
• Fluent in English
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 28709880 BACKGROUND

• 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.

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

  BACKGROUND

• 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.

  PMID: 26106540 BACKGROUND

• 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.

  PMID: 22713421 BACKGROUND

• 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.

  PMID: 22858178 BACKGROUND

• 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.

  PMID: 17889600 BACKGROUND

• 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.

  PMID: 30128538 BACKGROUND

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

  PMID: 26447583 BACKGROUND

• 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.

  PMID: 21414995 BACKGROUND

• 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.

  PMID: 24461998 BACKGROUND

• 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.

  PMID: 23785325 BACKGROUND

• 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.

  PMID: 26973515 BACKGROUND

• 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.

  PMID: 27163249 BACKGROUND

• 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.

  PMID: 30421472 BACKGROUND

• Shah-Basak PP, Norise C, Garcia G, Torres J, Faseyitan O, Hamilton RH. Individualized treatment with transcranial direct current stimulation in patients with chronic non-fluent aphasia due to stroke. Front Hum Neurosci. 2015 Apr 21;9:201. doi: 10.3389/fnhum.2015.00201. eCollection 2015.

  PMID: 25954178 BACKGROUND

MeSH Terms

Conditions

Aphasia; Stroke; Language; Language Disorders

Condition Hierarchy (Ancestors)

Speech Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Communication; Behavior

Study Officials

• Priyanka Shah-Basak, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sidney Schoenrock, MA

CONTACT

414-955-7579; sschoenrock@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priyanka Shah-Basak, PhD

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: January 4, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)