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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 weeks
Treatment ~ Varies
Follow Up ~60-300 ms after each tms stimulus
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60-300 ms after each tms stimulus for reporting.

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
1,428 Previous Clinical Trials
1,620,649 Total Patients Enrolled
Alik WidgePrincipal InvestigatorUniversity of Minnesota

Media Library

Healthy control Clinical Trial Eligibility Overview. Trial Name: NCT05962385 — Phase 4
Healthy Subjects Research Study Groups: Healthy control
Healthy Subjects Clinical Trial 2023: Healthy control Highlights & Side Effects. Trial Name: NCT05962385 — Phase 4
Healthy control 2023 Treatment Timeline for Medical Study. Trial Name: NCT05962385 — Phase 4
~4 spots leftby Feb 2025
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