Personalized Theta-burst Stimulation for Long-lasting Changes in Approach/Avoidance Behavior

NCT07161505 | Recruiting FDA Device

• 2 other identifiers: STU00223602R00MH128454
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the long-lasting effects of personalized theta burst stimulation (TBS), a repetitive form of transcranial magnetic stimulation (TMS), over the left prefrontal cortex on the approach/avoidance behavior. TBS will be personalized based on the prefrontal theta rhythm captured with electroencephalography (EEG). The main questions it aims to answer are: 1. does a single session of personalized TBS synchronized with the individual theta rhythm over the left prefrontal cortex results in the outlasting changes in the individual behavior? 2. Does TBS results in the brain rhythms' changes as measured using resting-state EEG?

Conditions

Approach/Avoidance Behavior

Outcome Measures

Primary Outcomes (1)

• Approach/avoidance behavior

  The changes in the reaction times (post-stimulation relative to pre-stimulation) for the correct responses in the approach/avoidance test.

  Within twenty minutes before and twenty minutes after the TBS procedure

Secondary Outcomes (2)

• Coherence

  Within twenty minutes before and twenty minutes after the TBS procedure

• Theta-gamma coupling

  Within twenty minutes before and twenty minutes after the TBS procedure

Study Arms (4)

Personalized TBS-EEG over the prefrontal cortex

EXPERIMENTAL

Theta burst stimulation (TBS) will be administrated with a figure-8 coil over the left dorsolateral prefrontal cortex (DLPFC) at the pulse intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be conducted at rest. The TBS parameters will be individualized to the prefrontal EEG activity (theta-gamma coupling) and delivered in synchrony with the prefrontal theta activity (phase). The approach/avoidance test and resting-state EEG recordings will be administered before and after the stimulation.

Device: TBS-EEG

Personalized TBS-EEG over the head vertex

ACTIVE COMPARATOR

Theta burst stimulation (TBS) will be administrated with a figure-8 coil over the postcentral gyrus (- a brain area with minimal functional relevance to the task) at the pulse intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be conducted at rest. The TBS parameters will be individualized to the prefrontal EEG activity (theta-gamma coupling) and delivered in synchrony with the prefrontal theta activity (phase). The approach/avoidance test and resting-state EEG recordings will be administered before and after the stimulation.

Device: TBS-EEG / Spatial Control

Conventional TBS over the prefrontal cortex

ACTIVE COMPARATOR

Theta burst stimulation (TBS) will be administrated with a figure-8 coil over the left dorsolateral prefrontal cortex (DLPFC) at the pulse intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be conducted at rest The TBS parameters will be randomized within the normative range of theta-gamma coupling (biomarker in the main experimental arm) and delivered in open-loop (irrespective of the EEG activity). The approach/avoidance test and resting-state EEG recordings will be administered before and after the stimulation.

Device: TBS / Temporal Control

Lower intensity personalized TBS-EEG

ACTIVE COMPARATOR

Theta burst stimulation (TBS) will be administrated with a figure-8 coil over the left dorsolateral prefrontal cortex (DLPFC) at the sub-threshold pulse intensity of up to 80% of the individualized resting motor threshold (rMT). Stimulation will be conducted at rest. The TBS parameters will be individualized to the prefrontal EEG activity (theta-gamma coupling) and delivered in synchrony with the prefrontal theta activity (phase). The approach/avoidance test and resting-state EEG recordings will be administered before and after the stimulation.

Device: TBS-EEG / Dose Control

Interventions

TBS-EEG DEVICE

Theta-burst stimulation (TBS) over the left dorsolateral prefrontal cortex (DLPFC) synchronized with the ongoing electroencephalographic (EEG) oscillations in the theta (3-7 Hz) range at a suprathreshold pulse intensity (up to 120% rMT).

Personalized TBS-EEG over the prefrontal cortex

TBS-EEG / Spatial Control DEVICE

Theta-burst stimulation (TBS) over the postcentral gyrus, synchronized with the ongoing electroencephalographic (EEG) oscillations in the theta (3-7 Hz) range at a suprathreshold pulse intensity (up to 120% rMT).

Personalized TBS-EEG over the head vertex

TBS / Temporal Control DEVICE

Theta-burst stimulation (TBS) over the left dorsolateral prefrontal cortex (DLPFC) at a suprathreshold pulse intensity (up to 120% rMT).

Conventional TBS over the prefrontal cortex

TBS-EEG / Dose Control DEVICE

Theta-burst stimulation (TBS) similar to the "TBS-EEG" condition but at a subthreshold pulse intensity (up to 80% rMT).

Lower intensity personalized TBS-EEG

Eligibility Criteria

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

You may qualify if:

• Participants must be legal adults between the ages of 18 to 65;
• Able and willing to complete study procedures and tasks.

You may not qualify if:

• History or evidence of chronic neurological or mental disorder;
• Chronic condition that requires pharmacological treatment over the course of study participation;
• Pregnancy or breastfeeding;
• History or evidence of alcohol or drug addiction;
• Contraindications for transcranial magnetic stimulation (history of seizures, metallic or electric implant in the head/neck area);
• Contraindications for magnetic resonance imaging at 3 Tesla (non-compatible implants, metallic foreign bodies, insulin pump, pacemaker).

Sponsors & Collaborators

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

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Study Officials

• Ivan Alekseichuk, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Alekseichuk, PhD

CONTACT

312-503-3196; neuromodlab@northwestern.edu

Study Design

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

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 8, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)