Theta Phase-specific TMS to Modulate Prefrontal Activity

NCT05416138 | Completed Results FDA Device

• 1 other identifier: STUDY00016214
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the causal link between the phase of ongoing theta oscillations in the prefrontal cortex and approach/avoidance (Ap/Av) behavior in adults using theta phase-specific transcranial magnetic stimulation (TMS).

Conditions

Approach/Avoidance Behavior

Outcome Measures

Primary Outcomes (1)

• Reaction Times in the Approach/Avoidance Test

  Reaction time (in milliseconds) in the Approach/Avoidance task during transcranial magnetic stimulation (TMS). TMS was synchronized to either the peaks or troughs of the participant's left prefrontal theta waves, in a randomized and counterbalanced order. The preregistered primary outcome measure is the average difference in reaction times between peak- and trough-synchronized stimulation stimuli. This statistical contrast specifically highlights the role of theta phase in phase-aligned stimulation.

  During the stimulation/task for each condition (approximately 6 minutes per run, 4 runs per condition).

Secondary Outcomes (1)

• Amplitude of TMS Evoked Potentials

  During the stimulation/task for each condition (approximately 6 minutes per run, 4 runs per condition).

Study Arms (2)

TMS over the left prefrontal cortex

EXPERIMENTAL

Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the left dorsolateral prefrontal cortex (DLPFC) at the intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing and stimulation per session is approximately 40 minutes (in 4 blocks with breaks in-between).

Device: Transcranial magnetic stimulation (TMS)

TMS over the head vertex

SHAM COMPARATOR

Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the head vertex at the intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing per session is approximately 40 minutes (in 4 blocks with breaks in-between).

Device: Transcranial magnetic stimulation (TMS)

Interventions

Transcranial magnetic stimulation (TMS) DEVICE

TMS will be performed at either peaks or troughs of ongoing prefrontal theta oscillations (3-7 Hz) concurrently with the cognitive test at the beginning of every test trial. Theta oscillations will be monitored in real-time at the left dorsolateral prefrontal cortex using electroencephalography (EEG).

TMS over the head vertex; TMS over the left prefrontal cortex

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 between 18 and 65 years old.
• Confident level of English language.

You may not qualify if:

• Chronic condition that requires pharmacological treatment over the course of study participation.
• Metallic or electric implant in the head, neck, or chest area or otherwise MRI-noncompatible implants.
• History or evidence of seizures, head injuries with loss of consciousness, chronic neurological or mental disorder.
• Pregnancy or breast-feeding.
• History or evidence of alcohol or drug addiction.

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Alexander Opitz
• Organization: University of Minnesota

aopitz@umn.edu

612-624-1094

Study Officials

• Alexander Opitz, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: November 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared only upon request after the study has ended (within 6 months).
• Access Criteria: To receive access, the study investigators need to be contacted via an institutional e-mail including a short description of the scientific or educational aims.

Locations

US (1)