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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).
Awards & highlights

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 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

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
620 Previous Clinical Trials
1,172,439 Total Patients Enrolled
Priyanka Shah-Basak, PhDPrincipal InvestigatorMedical College of Wisconsin
1 Previous Clinical Trials
50 Total Patients Enrolled
~90 spots leftby Jun 2032
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