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TMS + tDCS for Neurological Disorders
N/A
Recruiting
Led By Zafer Keser, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of TMS and tDCS as a way to improve diagnosis of neurological disorders.
Who is the study for?
This trial is for individuals with brain injuries from strokes or trauma, who don't have any ongoing neurological disorders. It's also open to healthy people. The study aims to include those who've experienced changes in their brain function due to injury.Check my eligibility
What is being tested?
The study tests the safety and diagnostic value of TMS-EEG before and after a session using experimental devices like repetitive Transcranial Magnetic Stimulation (rTMS) or transcranial Direct Current Stimulation (tDCS).See study design
What are the potential side effects?
Possible side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however, these are generally rare and will be closely monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Modified Rankin Scale
Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ)
Change in neurological outcome (NIHSS)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Stroke SubjectsExperimental Treatment3 Interventions
Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols
Group II: Non-Stroke SubjectsExperimental Treatment3 Interventions
Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730
Electroencephalogram
2012
N/A
~90
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,766,998 Total Patients Enrolled
Zafer Keser, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any metal implants that prevent MRI or TMS scans.I do not have any active neurological disorders.I have had a stroke or traumatic brain injury.I have a history of epilepsy.I have severe difficulty speaking due to a stroke.I have a history of active or treatment-resistant depression.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Stroke Subjects
- Group 2: Stroke Subjects
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are fresh participants being taken for this research study?
"Yes, the information posted on clinicaltrials.gov attests to this medical trial's current recruitment state. It was initially launched on July 1st 2022 and its details were recently modified as of July 22nd 2022. Forty individuals can join from a single locale."
Answered by AI
How many participants are currently involved in this medical experiment?
"Affirmative. The clinicaltrials.gov website indicates that this research project is actively recruiting participants, having been posted on July 1st 2022 and last updated on July 22nd of the same year. A total of 40 volunteers need to be sourced from a single location."
Answered by AI
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