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RecruitingNCT07161505Updated Aug 18, 2026

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

An interventional study of TBS-EEG and TBS-EEG / Spatial Control in Approach/Avoidance Behavior, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Northwestern University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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?

Read the 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.

02

Conditions studied

  • Approach/Avoidance Behavior
03

In context

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Personalized TBS-EEG over the prefrontal cortex

    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

  • Active comparator
    Personalized TBS-EEG over the head vertex

    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

  • Active comparator
    Conventional TBS over the prefrontal cortex

    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

  • Active comparator
    Lower intensity personalized TBS-EEG

    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

  • DeviceTBS-EEG

    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).

  • DeviceTBS-EEG / Spatial Control

    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).

  • DeviceTBS / Temporal Control

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

  • DeviceTBS-EEG / Dose Control

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

06

What researchers measure

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.

    Time frame: Within twenty minutes before and twenty minutes after the TBS procedure

Secondary outcomes

  1. Coherence

    The changes in the multivariate coherence in the electroencephalography (EEG) post-stimulation relative to pre-stimulation.

    Time frame: Within twenty minutes before and twenty minutes after the TBS procedure

  2. Theta-gamma coupling

    The changes in the theta-gamma coupling (statistical covariation of theta and gamma oscillations) in the electroencephalography (EEG) post-stimulation relative to pre-stimulation.

    Time frame: Within twenty minutes before and twenty minutes after the TBS procedure

07

Study locations

1 of 1 sites recruiting
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60611, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Full or partial access to trial IPD will be provided upon the request from qualified researchers at recognized research, medical, and educational institutions for educational and scientific purposes, and following execution of a data sharing agreement. The request should be sent via an institutional email and will be stored with the study materials. The request should include a short description of the scientific or educational aims. Fully de-identified data will be shared with the scientific community via an open repository following the publication describing the data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07161505
Lead sponsor
Northwestern University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Sep 8, 2025
Start date
Jul 31, 2025
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

Ivan Alekseichuk, PhD
Contact
neuromodlab@northwestern.edu
312-503-3196
Ivan Alekseichuk, PhD
principal investigator · Northwestern University

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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