Language Processing and TMS

NCT05425615 | Recruiting FDA Device

• 1 other identifier: 43228
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Aphasia; Language

Keywords

TMS; Transcranial Magnetic Stimulation; Aphasia; Semantic processing; Phonological processing

Outcome Measures

Primary Outcomes (2)

• Reaction time on language task performance

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

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

• Accuracy on language task performance

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

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

Study Arms (3)

Active TMS

EXPERIMENTAL

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

Control TMS

ACTIVE COMPARATOR

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 TMS

SHAM COMPARATOR

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

Transcranial Magnetic Stimulation DEVICE

Deymed DuoMag XT-100 rTMS

Also known as: TMS

Active TMS; Control TMS; Sham TMS

Eligibility Criteria

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

You may qualify if:

• Diagnosed with left hemisphere stroke
• Consent date \>= 1 month 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
• 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
• cardiac stimulators or pacemakers or intracardiac lines
• neurostimulators
• medication infusion device
• any other implants near the scalp (e.g., cochlear implants) or in the eye
• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (22)

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• 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.

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• Epstein CM. Transcranial magnetic stimulation: language function. J Clin Neurophysiol. 1998 Jul;15(4):325-32. doi: 10.1097/00004691-199807000-00004.

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• Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026.

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• 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.

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• 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.

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• 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.

  PMID: 11332408 BACKGROUND

• 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.

  PMID: 29881801 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 21221011 BACKGROUND

• 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.

  PMID: 10466148 BACKGROUND

• 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.

  PMID: 10753803 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

  PMID: 9743275 BACKGROUND

• 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.

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  PMID: 11252771 BACKGROUND

• 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.

  PMID: 9474057 BACKGROUND

• 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.

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MeSH Terms

Conditions

Stroke; Aphasia; Language

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Priyanka Shah-Basak, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sidney Schoenrock

CONTACT

414-955-7579; sschoenrock@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and outcomes assessor will both be blinded to intervention modalities.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Multiple studies will be conducted in parallel. But within a study, the interventional assignment will be set to cross-over with 3-4 arms.

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 21, 2022
• Study Start: June 5, 2024
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): June 1, 2032
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)