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Transcranial Magnetic Stimulation During Cognitive Tasks for Healthy Subjects
Phase 4
Recruiting
Led By Alik Widge
Research Sponsored by University of Minnesota
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 60-300 ms after each tms stimulus
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will look at whether brain stimulation and cognitive tasks can help improve mental functioning. Participants will do tasks while receiving transcranial magnetic stimulation and brain activity will be measured.
Who is the study for?
This trial is for healthy individuals aged between 18 and 65. Participants should not be pregnant, have metal in their head (except dental fillings), diagnosed psychiatric disorders, epilepsy or history of seizures, recent concussions, adverse reactions to TMS/MRI, neurological conditions like stroke or tinnitus, or implanted medical devices.
What is being tested?
The study tests if engaging in cognitive or perceptual tasks while receiving transcranial magnetic stimulation (TMS) can enhance mental function. It involves two sessions where brain function changes are measured with EEG during the application of TMS.
What are the potential side effects?
While side effects are rare for TMS when used on healthy subjects, they may include discomfort at the stimulation site, headache, lightheadedness, and a very low risk of seizure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60-300 ms after each tms stimulus
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60-300 ms after each tms stimulus
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cortical excitability
Theta-gamma cross frequency coupling
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Healthy controlExperimental Treatment1 Intervention
All participants receive the same procedures
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,436 Previous Clinical Trials
1,621,761 Total Patients Enrolled
Alik WidgePrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I have epilepsy or have had a seizure before.I have been diagnosed with a condition like stroke or tinnitus.I am currently using, or have recently stopped using, medication that could increase my risk of seizures.I have been diagnosed with a concussion from a head injury.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy control
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.