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

Not Applicable

Recruiting

• Conditions: Approach/Avoidance Behavior

• Registration Number: NCT07161505
• Lead Sponsor: Northwestern University

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?

Detailed Description

This is a double-blinded, counterbalanced crossover study in healthy adults. Volunteers will participate in four TBS-EEG sessions. In each, the investigators will first conduct the approach/avoidance test with EEG. The TBS pulse intensity will be defined according to the resting motor threshold (rMT). After the approach/avoidance test, one of four conditions will be delivered in a randomized order: 1. Verum: personalized closed-loop TBS-EEG stimulation over the left DLPFC at a suprathreshold pulse intensity (up to 120% rMT); 2. Spatial control: personalized TBS stimulation over the functionally irrelevant postcentral gyrus, 3. Temporal control: conventional (non-personalized) TBS with random parameters but the same number of pulses over conventionally defined DLPFC. 4. Dose control: similar to verum but at a subthreshold pulse intensity (up to 80% rMT). At every session, 1,800 pulses will be applied. Following the stimulation, the participant will repeat the approach/avoidance test with EEG.

Study Timeline

• Study Start: 2025-07-31
• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Approach/avoidance behavior	Within twenty minutes before and twenty minutes after the TBS procedure	The changes in the reaction times (post-stimulation relative to pre-stimulation) for the correct responses in the approach/avoidance test.

Secondary Outcome Measures

Name	Time	Method
Coherence	Within twenty minutes before and twenty minutes after the TBS procedure	The changes in the multivariate coherence in the electroencephalography (EEG) post-stimulation relative to pre-stimulation.
Theta-gamma coupling	Within twenty minutes before and twenty minutes after the TBS procedure	The changes in the theta-gamma coupling (statistical covariation of theta and gamma oscillations) in the electroencephalography (EEG) post-stimulation relative to pre-stimulation.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States