State Dependence of Prefrontal Transcranial Magnetic Stimulation

The study will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while receiving transcranial magnetic stimulation. The study will measure change in brain function with EEG.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Brain state while receiving TMS

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 - 65,
• healthy controls

Exclusion Criteria:

• Diagnosed psychiatric disorder
• Potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
• Potential contraindication to TMS (as identified by the TMS safety screener)
• Any previous adverse reaction to TMS or MRI
• Diagnosed epilepsy or previously experienced a seizure
• Diagnosed neurological condition, such as stroke or tinnitus
• Experienced a head trauma that was diagnosed as concussion
• Current use of, or recent withdrawal from, medications that can increase the risk of seizure
• Currently pregnant
• Any metal in the head (excluding mouth)
• Any implanted medical device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy control; All participants receive the same procedures	Device: Brain state while receiving TMS; Brain state whilst receiving TMS - cognitive control or perceptual. Repeated measures design, so all participants receive the same procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Theta-gamma cross frequency coupling	A metric of brain function measured with EEG - the coupling of theta oscillation phase with gamma power. This will be measured immediately following the intervention (TMS stimulation).	0-500 ms after each TMS stimulus
Cortical excitability	TMS-evoked potentials will be measured with EEG to examine cortical excitability after TMS. This will be measured immediately following the intervention (TMS stimulation).	60-300 ms after each TMS stimulus

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Alik Widge, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2023
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): November 17, 2025

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PSYCH-2023-32060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No