Language Processing and TMS

NCT ID: NCT05425615

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2032-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke Aphasia Language

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participant and outcomes assessor will both be blinded to intervention modalities.

Study Groups

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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.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Deymed DuoMag XT-100 rTMS

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.

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Deymed DuoMag XT-100 rTMS

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.

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Deymed DuoMag XT-100 rTMS

Interventions

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Transcranial Magnetic Stimulation

Deymed DuoMag XT-100 rTMS

Intervention Type DEVICE

Other Intervention Names

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TMS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Priyanka Shah-Basak, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Priyanka Shah-Basak, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sidney Schoenrock

Role: CONTACT

414-955-7579

Facility Contacts

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Sidney Schoenrock, MS

Role: primary

414-955-7579

References

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Other Identifiers

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43228

Identifier Type: -

Identifier Source: org_study_id

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