Personalized Theta-burst Stimulation for Long-lasting Changes in Approach/Avoidance Behavior
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TBS-EEG, TBS-EEG / Spatial Control, TBS / Temporal Control, TBS-EEG / Dose Control.
- Who it may be relevant to
- Registry conditions: Approach/Avoidance Behavior. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficiency of Personalized Theta-burst Stimulation for Inducing Long-lasting Changes in DLPFC
Overview
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
- Device TBS-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). - Device TBS-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). - Device TBS / Temporal Control
Theta-burst stimulation (TBS) over the left dorsolateral prefrontal cortex (DLPFC) at a suprathreshold pulse intensity (up to 120% rMT). - Device TBS-EEG / Dose Control
Theta-burst stimulation (TBS) similar to the "TBS-EEG" condition but at a subthreshold pulse intensity (up to 80% rMT).
Primary outcome measures
- Approach/avoidance behavior [Time frame: Within twenty minutes before and twenty minutes after the TBS procedure]
Secondary outcome measures (2)
- Coherence [Time frame: Within twenty minutes before and twenty minutes after the TBS procedure]
- Theta-gamma coupling [Time frame: Within twenty minutes before and twenty minutes after the TBS procedure]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Northwestern University Feinberg School of Medicine — Chicago
Identifiers
NCT: NCT07161505 · STU00223602 · R00MH128454