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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07161505
Status
Recruiting

Conditions

  • Approach/Avoidance Behavior

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

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).
  • 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).

Study Details

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?

Key Dates

Start date
Jul 31, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Approach/avoidance behavior [ Time Frame: Within twenty minutes before and twenty minutes after the TBS procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Ivan Alekseichuk, PhD
312-503-3196

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