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NCT Number: NCT07161505

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

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?

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Ivan Alekseichuk, PhD

CONTACT

[email protected]

312-503-3196

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

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).

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).

TBS / Temporal Control

Device

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

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).

Primary outcomes

  1. Approach/avoidance behavior

    Time frame: 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 outcomes

  1. Coherence

    Time frame: 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.

  2. Theta-gamma coupling

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ivan Alekseichuk, PhD

CONTACT

[email protected]

312-503-3196

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

The Efficiency of Personalized Theta-burst Stimulation for Inducing Long-lasting Changes in DLPFC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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