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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07161505
Enrollment
26
Registered
2025-09-08
Start date
2025-07-31
Completion date
2027-02-28
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Approach/Avoidance Behavior

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.

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).

Sponsors

Northwestern University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

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).

Design outcomes

Primary

MeasureTime frameDescription
Approach/avoidance behaviorWithin twenty minutes before and twenty minutes after the TBS procedureThe changes in the reaction times (post-stimulation relative to pre-stimulation) for the correct responses in the approach/avoidance test.

Secondary

MeasureTime frameDescription
CoherenceWithin twenty minutes before and twenty minutes after the TBS procedureThe changes in the multivariate coherence in the electroencephalography (EEG) post-stimulation relative to pre-stimulation.
Theta-gamma couplingWithin twenty minutes before and twenty minutes after the TBS procedureThe changes in the theta-gamma coupling (statistical covariation of theta and gamma oscillations) in the electroencephalography (EEG) post-stimulation relative to pre-stimulation.

Countries

United States

Contacts

CONTACTIvan Alekseichuk, PhD
neuromodlab@northwestern.edu312-503-3196
PRINCIPAL_INVESTIGATORIvan Alekseichuk, PhD

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026