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Language Processing and TMS

Primary Purpose

Stroke, Aphasia, Language

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Transcranial Magnetic Stimulation

About this trial

This is an interventional basic science trial for Stroke focused on measuring TMS, Transcranial Magnetic Stimulation, Aphasia, Semantic processing, Phonological processing

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Active TMS

Control TMS

Sham TMS

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Reaction time on language task performance

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

Accuracy on language task performance

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05425615

First Posted

June 7, 2022

Last Updated

October 17, 2023

Sponsor

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT05425615

Brief Title

Language Processing and TMS

Official Title

Probing Language Processes Using Transcranial Magnetic Stimulation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2024 (Anticipated)

Primary Completion Date

June 2032 (Anticipated)

Study Completion Date

June 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Aphasia, Language

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantOutcomes Assessor

Masking Description

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

Allocation

Non-Randomized

Enrollment

135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active TMS

Arm Type

Experimental

Arm Description

Arm Title

Control TMS

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Sham TMS

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Transcranial Magnetic Stimulation

Other Intervention Name(s)

TMS

Intervention Description

Deymed DuoMag XT-35 rTMS

Primary Outcome Measure Information:

Title

Reaction time on language task performance

Description

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).

Title

Accuracy on language task performance

Description

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Isabelle Banke

Phone

414-955-4485

ibanke@mcw.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Samantha Hudson

Phone

414-955-5891

samhudson@mcw.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Priyanka Shah-Basak, PhD

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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Language Processing and TMS

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