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Language Processing and TMS

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05425615
Collaborator
(none)
135
Enrollment
3
Arms
120
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
135 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multiple studies will be conducted in parallel. But within a study, the interventional assignment will be set to cross-over with 3-4 arms.Multiple studies will be conducted in parallel. But within a study, the interventional assignment will be set to cross-over with 3-4 arms.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The participant and outcomes assessor will both be blinded to intervention modalities.
Primary Purpose:
Basic Science
Official Title:
Probing Language Processes Using Transcranial Magnetic Stimulation
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2032
Anticipated Study Completion Date :
Jun 1, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active TMS

Deymed DuoMag XT-35 rTMS system (DM-XT35) 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-35 rTMS
Other Names:
  • TMS

    		•
    Active Comparator: Control TMS

    Deymed DuoMag XT-35 rTMS system (DM-XT35) 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-35 rTMS
    Other Names:
  • TMS

    		•
    Sham Comparator: Sham TMS

    Deymed DuoMag XT-35 rTMS system (DM-XT35) 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-35 rTMS
    Other Names:
  • TMS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reaction time on language task performance [Language tasks administered immediately before and/or after TMS administration (same day).]

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

    2. Accuracy on language task performance [Language tasks administered immediately before and/or after TMS administration (same day).]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medical College of Wisconsin

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Priyanka Shah-Basak, PhD, Assistant Professor, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT05425615
    Other Study ID Numbers:
    • 43228
    First Posted:
    Jun 21, 2022
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Priyanka Shah-Basak, PhD, Assistant Professor, Medical College of Wisconsin
    TMS
    Transcranial Magnetic Stimulation
    Aphasia
    Semantic processing
    Phonological processing
    Additional relevant MeSH terms:
    Aphasia

    Study Results

    No Results Posted as of Jun 21, 2022