State Dependence of Prefrontal Transcranial Magnetic Stimulation

NCT05962385 | Completed Phase 4 FDA Device

• 1 other identifier: PSYCH-2023-32060
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Healthy control

EXPERIMENTAL

All participants receive the same procedures

Device: Brain state while receiving TMS

Interventions

Brain state while receiving TMS DEVICE

Brain state whilst receiving TMS - cognitive control or perceptual. Repeated measures design, so all participants receive the same procedures.

Healthy control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65,
• healthy controls

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Alik Widge

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding is possible
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated measures design - across two separate sessions (one week apart, counterbalanced between participants), participants will receive transcranial magnetic stimulation (TMS) whilst engaging in either a cognitive control or a perceptual task.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 27, 2023
• Study Start: August 24, 2023
• Primary Completion: July 31, 2025
• Study Completion: November 17, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)