Language Processing and TMS

Not Applicable

Recruiting

• Conditions: Language; Stroke; Aphasia
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT05425615
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-21
• Study Start: 2024-06-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• Primary Completion: 2032-06
• Study Completion: 2032-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control TMS	Transcranial Magnetic Stimulation	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.
Sham TMS	Transcranial Magnetic Stimulation	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.
Active TMS	Transcranial Magnetic Stimulation	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States