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RecruitingNCT05425615Updated Jul 13, 2026

Language Processing and TMS

An interventional study of Transcranial Magnetic Stimulation in Stroke, Aphasia and Language, sponsored by Medical College of Wisconsin. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
135
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This study will examine the effect of TMS on people with stroke and aphasia as well as healthy individuals.

Read the detailed description

To examine the brain's structure and specific language function and interactive relationships, investigators will implement repetitive or rapid TMS protocols in an active (or sham)-controlled, within-subject, randomized studies. Aims will evaluate the effects of short-term changes on each of the semantic or phonological language process of interest in isolation and changes in the interaction between language sub-processes and their interaction with other cognitive domains that directly or indirectly affect language functions. The brain targets for TMS application will be informed by existing evidence on (correlational but not causal) associations between language regions and specific language processes from numerous prior neuroimaging (e.g., functional magnetic resonance imaging or fMRI) and neuropsychological studies. Healthy individuals and/or stroke survivors with aphasia will be recruited to address these aims.

02

Conditions studied

  • Stroke
  • Aphasia
  • Language

Keywords

  • TMS
  • Transcranial Magnetic Stimulation
  • Aphasia
  • Semantic processing
  • Phonological processing
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 135 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with left hemisphere stroke
  • Consent date >= 1 month after stroke onset
  • Right-handed
  • Fluent in English
  • 18 years of age or older

Exclusion criteria

Exclusion Criteria:

  • Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
  • Non-decisional per decisionality questionnaire or other clinical assessment
  • Presence of major untreated or unstable psychiatric disease (e.g. schizophrenia, bipolar disease)
  • A chronic medical condition that is not treated or is unstable
  • Presence of

    1. cardiac stimulators or pacemakers or intracardiac lines
    2. neurostimulators
    3. medication infusion device
    4. any other implants near the scalp (e.g., cochlear implants) or in the eye
    5. metal in the body
  • Pregnancy
  • History of skull fractures, or skin diseases
  • History of ongoing or unmanaged seizures or a family history of epilepsy
  • Presence of factors that potentially decrease seizure thresholds
  • On pro-convulsant medications
  • Untreated Sleep deprivation or insomnia
  • Ongoing alcoholism or illegal drug abuse (e.g., cocaine or MDMA users)
  • History of dyslexia or other developmental learning disabilities
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
135 participants (estimated)

Study arms

  • Experimental
    Active TMS

    Deymed DuoMag XT-100 rTMS system (DM-XT100) connected to a 70-mm figure-of-eight coil with built-in cooling fans (also known as an air-cooled coil) will be used for delivering active repetitive or rapid TMS to the target site.

    Device: Transcranial Magnetic Stimulation

  • Active comparator
    Control TMS

    Deymed DuoMag XT-100 rTMS system (DM-XT100) connected to a 70-mm figure-of-eight coil with built-in cooling fans will be used for delivering active repetitive or rapid TMS to the control site.

    Device: Transcranial Magnetic Stimulation

  • Sham comparator
    Sham TMS

    Deymed DuoMag XT-100 rTMS system (DM-XT100) connected to a 70-mm figure-of-eight coil with built-in cooling fans will be used for delivering sham repetitive or rapid TMS to the control or target site.

    Device: Transcranial Magnetic Stimulation

Interventions

  • DeviceTranscranial Magnetic Stimulation

    Deymed DuoMag XT-100 rTMS

    Also known as: TMS

06

What researchers measure

Primary outcomes

  1. Reaction time on language task performance

    Improvement on language task performance as measured by decrease in reaction time.

    Time frame: Language tasks administered immediately before and/or after TMS administration (same day).

  2. Accuracy on language task performance

    Improvement on language task performance as measured by increase in accuracy.

    Time frame: Language tasks administered immediately before and/or after TMS administration (same day).

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398. PubMed 9153480 ↗
  • Devlin JT, Watkins KE. Stimulating language: insights from TMS. Brain. 2007 Mar;130(Pt 3):610-22. doi: 10.1093/brain/awl331. Epub 2006 Nov 29. PubMed 17138570 ↗
  • Epstein CM. Transcranial magnetic stimulation: language function. J Clin Neurophysiol. 1998 Jul;15(4):325-32. doi: 10.1097/00004691-199807000-00004. PubMed 9736466 ↗
  • Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026. PubMed 17640522 ↗
  • Hamilton RH, Chrysikou EG, Coslett B. Mechanisms of aphasia recovery after stroke and the role of noninvasive brain stimulation. Brain Lang. 2011 Jul;118(1-2):40-50. doi: 10.1016/j.bandl.2011.02.005. Epub 2011 Apr 2. PubMed 21459427 ↗
  • Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. PubMed 15664172 ↗
  • Keel JC, Smith MJ, Wassermann EM. A safety screening questionnaire for transcranial magnetic stimulation. Clin Neurophysiol. 2001 Apr;112(4):720. doi: 10.1016/s1388-2457(00)00518-6. No abstract available. PubMed 11332408 ↗
  • Lehtinen H, Makela JP, Makela T, Lioumis P, Metsahonkala L, Hokkanen L, Wilenius J, Gaily E. Language mapping with navigated transcranial magnetic stimulation in pediatric and adult patients undergoing epilepsy surgery: Comparison with extraoperative direct cortical stimulation. Epilepsia Open. 2018 Apr 6;3(2):224-235. doi: 10.1002/epi4.12110. eCollection 2018 Jun. PubMed 29881801 ↗
  • Lerner AJ, Wassermann EM, Tamir DI. Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Clin Neurophysiol. 2019 Aug;130(8):1409-1416. doi: 10.1016/j.clinph.2019.03.016. Epub 2019 Apr 6. PubMed 31104898 ↗
  • Narayana S, Gibbs SK, Fulton SP, McGregor AL, Mudigoudar B, Weatherspoon SE, Boop FA, Wheless JW. Clinical Utility of Transcranial Magnetic Stimulation (TMS) in the Presurgical Evaluation of Motor, Speech, and Language Functions in Young Children With Refractory Epilepsy or Brain Tumor: Preliminary Evidence. Front Neurol. 2021 May 19;12:650830. doi: 10.3389/fneur.2021.650830. eCollection 2021. PubMed 34093397 ↗
  • Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f. PubMed 21221011 ↗
  • Pascual-Leone A, Bartres-Faz D, Keenan JP. Transcranial magnetic stimulation: studying the brain-behaviour relationship by induction of 'virtual lesions'. Philos Trans R Soc Lond B Biol Sci. 1999 Jul 29;354(1387):1229-38. doi: 10.1098/rstb.1999.0476. PubMed 10466148 ↗
  • Pascual-Leone A, Walsh V, Rothwell J. Transcranial magnetic stimulation in cognitive neuroscience--virtual lesion, chronometry, and functional connectivity. Curr Opin Neurobiol. 2000 Apr;10(2):232-7. doi: 10.1016/s0959-4388(00)00081-7. PubMed 10753803 ↗
  • Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24. PubMed 33243615 ↗
  • Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. PubMed 19833552 ↗
  • Rossi S, Hallett M, Rossini PM, Pascual-Leone A. Screening questionnaire before TMS: an update. Clin Neurophysiol. 2011 Aug;122(8):1686. doi: 10.1016/j.clinph.2010.12.037. Epub 2011 Jan 11. No abstract available. PubMed 21227747 ↗
  • Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10. PubMed 25797650 ↗
  • Rossini PM, Rossi S. Clinical applications of motor evoked potentials. Electroencephalogr Clin Neurophysiol. 1998 Mar;106(3):180-94. doi: 10.1016/s0013-4694(97)00097-7. PubMed 9743275 ↗
  • Shrout PE, Rodgers JL. Psychology, Science, and Knowledge Construction: Broadening Perspectives from the Replication Crisis. Annu Rev Psychol. 2018 Jan 4;69:487-510. doi: 10.1146/annurev-psych-122216-011845. PubMed 29300688 ↗
  • Walsh V, Cowey A. Transcranial magnetic stimulation and cognitive neuroscience. Nat Rev Neurosci. 2000 Oct;1(1):73-9. doi: 10.1038/35036239. PubMed 11252771 ↗
  • Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8. PubMed 9474057 ↗
  • Wilson SM, Eriksson DK, Schneck SM, Lucanie JM. A quick aphasia battery for efficient, reliable, and multidimensional assessment of language function. PLoS One. 2018 Feb 9;13(2):e0192773. doi: 10.1371/journal.pone.0192773. eCollection 2018. PubMed 29425241 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Jun 2032, 96 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 96 months is above that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2022
First posted
Jun 21, 2022
StartActual
Jun 5, 2024
Primary completionEst.
Jun 2032
CompletionEst.
Jun 2032
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05425615
Responsible party
Priyanka Shah-Basak, PhD (Assistant Professor, Medical College of Wisconsin) — Principal investigator
First posted
Jun 21, 2022
Start date
Jun 5, 2024
Primary completion
Jun 2032 (estimated)
Completion
Jun 2032 (estimated)
Last update
Jul 13, 2026

Study contacts

Sidney Schoenrock
Contact
sschoenrock@mcw.edu
414-955-7579
Priyanka Shah-Basak, PhD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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