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Transcranial Magnetic Stimulation

TMS for Aphasia

N/A

Recruiting

Led By Priyanka Shah-Basak, PhD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with left hemisphere stroke

18 years of age or older

Must not have

A chronic medical condition that is not treated or is unstable

History of skull fractures, or skin diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up language tasks administered immediately before and/or after tms administration (same day).

Summary

"This trial will look at how TMS impacts individuals who have had a stroke and have difficulty with language, as well as healthy individuals."

Who is the study for?

This trial is for right-handed, English-speaking adults over 18 who've had a left hemisphere stroke at least one month ago and are experiencing language difficulties. It's not suitable for those with implants near the scalp, metal in their body, seizure risks, heart devices, untreated major psychiatric conditions or cognitive impairments.

What is being tested?

The study investigates the impact of Transcranial Magnetic Stimulation (TMS) on language processing in individuals who have suffered from a stroke leading to aphasia as well as in healthy participants.

What are the potential side effects?

While TMS is generally considered safe, potential side effects may include discomfort at the stimulation site, headache, lightheadedness or seizures; however seizures are rare. The risk varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a stroke affecting the left side of my brain.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a chronic condition that is untreated or not under control.

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I have had skull fractures or skin diseases in the past.

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I do not have untreated or unstable major psychiatric conditions.

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I have conditions that could make seizures more likely.

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I am taking medication that can cause seizures.

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I have seizures that are not under control or a family history of epilepsy.

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I have not treated my sleep deprivation or insomnia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ language tasks administered immediately before and/or after tms administration (same day).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~language tasks administered immediately before and/or after tms administration (same day).

This trial's timeline: 3 weeks for screening, Varies for treatment, and language tasks administered immediately before and/or after tms administration (same day). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy on language task performance

Reaction time on language task performance

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Active TMSExperimental Treatment1 Intervention

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 II: Control TMSActive Control1 Intervention

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 III: Sham TMSPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

0 / 9Eligibility criteria met