State Dependence of Prefrontal Transcranial Magnetic Stimulation

Healthy Clinical Trial

Official title:

State Dependence of Prefrontal Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962385
• Other study ID #: PSYCH-2023-32060
• Status: Recruiting
• Phase: Phase 4
• Start date: August 24, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: August 2023
• Source: University of Minnesota
• Contact: Aaron Mclnnes, PhD
• Phone: 612-300-7801
• Email: mcinn125[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 10, 2024
• Est. primary completion date: March 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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