Language Processing and TMS

May 8, 2025 updated by: Priyanka Shah-Basak, PhD, Medical College of Wisconsin

Probing Language Processes Using Transcranial Magnetic Stimulation

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Deymed DuoMag XT-100 rTMS
Other Names:
  • TMS
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
Deymed DuoMag XT-100 rTMS
Other Names:
  • TMS
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
Deymed DuoMag XT-100 rTMS
Other Names:
  • TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaction time on language task performance
Time Frame: Language tasks administered immediately before and/or after TMS administration (same day).
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
Time Frame: Language tasks administered immediately before and/or after TMS administration (same day).
Improvement on language task performance as measured by increase in accuracy.
Language tasks administered immediately before and/or after TMS administration (same day).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Priyanka Shah-Basak, PhD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2024

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

June 1, 2032

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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