State Dependence of Prefrontal Transcranial Magnetic Stimulation

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05962385

Collaborator

(none)

Enrollment

Location

Arm

10.5

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Brain state while receiving TMS	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Masking Description:

No blinding is possible

Primary Purpose:

Basic Science

Official Title:

State Dependence of Prefrontal Transcranial Magnetic Stimulation

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 16, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Theta-gamma cross frequency coupling [0-500 ms after each TMS stimulus]
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).
Cortical excitability [60-300 ms after each TMS stimulus]
TMS-evoked potentials will be measured with EEG to examine cortical excitability after TMS. This will be measured immediately following the intervention (TMS stimulation).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator: Alik Widge, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT05962385

Other Study ID Numbers:

PSYCH-2023-32060

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Jul 27, 2023