Personalized Theta-burst Stimulation for Approach/Avoidance Conflict

Overseen By Ivan Alekseichuk, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Neurological disorder, Mental disorder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 sessions

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of brain stimulation called personalized theta-burst stimulation (TBS) to determine its effect on reactions in approach/avoidance situations. The researchers aim to discover if a single session of this treatment can lead to lasting changes in behavior and brain activity. The trial will compare different TBS delivery methods, including personalized and traditional approaches. Suitable candidates have no history of chronic neurological or mental disorders and are not currently on long-term medications. As an unphased trial, this study offers a unique opportunity to contribute to cutting-edge research and potentially benefit from innovative treatment methods.

Will I have to stop taking my current medications?

The trial excludes participants with chronic conditions that require ongoing medication, so you may not be able to participate if you need to keep taking your current medications.

What prior data suggests that personalized theta-burst stimulation is safe?

Research has shown that theta-burst stimulation (TBS) is generally safe. This technique uses magnetic pulses to affect brain activity. Studies indicate that both personalized and standard TBS are well-tolerated. Some people might experience mild side effects, such as headaches or scalp discomfort, but these usually resolve quickly. Experts advise caution because TBS remains relatively new, so practitioners apply it carefully. Current research has not identified any serious negative effects of TBS on the prefrontal cortex, a part of the brain involved in complex behaviors and decision-making. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Personalized Theta-burst Stimulation (TBS) for approach/avoidance conflict because it offers a tailored approach to brain stimulation, unlike conventional treatments. This technique uses a figure-8 coil to deliver pulses in sync with the brain's natural rhythms, specifically targeting the prefrontal cortex and adjusting to each individual's brain activity patterns. The personalized aspect of this method distinguishes it from standard care options, which typically do not account for individual EEG activity. By potentially enhancing the brain's natural processes, this treatment could offer quicker and more efficient results, making it a promising alternative to existing therapies.

What evidence suggests that this trial's treatments could be effective for approach/avoidance behavior?

Research has shown that personalized theta-burst stimulation (TBS) can influence brain activity by targeting specific brain rhythms. TBS, a form of repetitive brain stimulation, uses a magnetic field to alter brain responses. In this trial, participants will receive various forms of TBS, including personalized TBS-EEG over the head vertex, personalized TBS-EEG over the prefrontal cortex, conventional TBS over the prefrontal cortex, and lower intensity personalized TBS-EEG. Personalizing TBS with brain rhythms measured by EEG (a test that records brain activity) may lead to lasting behavioral changes. Early findings suggest that aligning TBS with an individual's unique brain rhythm could enhance their reactions to situations, potentially reducing anxiety or hesitation in decision-making. ^{6 7 8 9 10}

Who Is on the Research Team?

Ivan Alekseichuk, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who can complete study tasks. It's not for those with chronic neurological or mental disorders, pregnant or breastfeeding individuals, people with a history of substance addiction, anyone with contraindications to TMS (like seizures or implants), and those on long-term medication.

Inclusion Criteria

I am between 18 and 65 years old.

I am willing and able to follow the study's requirements.

Exclusion Criteria

History or evidence of chronic neurological or mental disorder

Pregnancy or breastfeeding

History or evidence of alcohol or drug addiction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo four TBS-EEG sessions with personalized theta burst stimulation over the left prefrontal cortex

4 sessions

4 visits (in-person)

Follow-up

Participants are monitored for changes in approach/avoidance behavior and EEG activity post-stimulation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Theta-burst Stimulation

Trial Overview

The study tests if personalized theta burst stimulation (TBS) over the left prefrontal cortex affects approach/avoidance behavior. It uses EEG to tailor TBS to individual brain rhythms and checks if one session can cause lasting behavioral changes and alter brain rhythms.

How Is the Trial Designed?

Group I: Personalized TBS-EEG over the prefrontal cortex Experimental Treatment 1 Intervention

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.

Group II: Personalized TBS-EEG over the head vertex Active Control 1 Intervention

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.

Group III: Conventional TBS over the prefrontal cortex Active Control 1 Intervention

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.

Group IV: Lower intensity personalized TBS-EEG Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07161505

Personalized Theta-burst Stimulation for Long-lasting ...

This study will assess the long-lasting effects of personalized theta burst stimulation (TBS), a repetitive form of transcranial magnetic ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11324911/

Theta-burst direct electrical stimulation remodels human brain ...

Here we show that individual bursts of direct electrical TBS at 29 frontal and temporal sites evoked strong neural responses spanning broad cortical regions.

3.

withpower.com

withpower.com/trial/phase-approachavoidance-behavior-6-2025-23e2a

Personalized Theta-burst Stimulation for Approach ...

This study will assess the long-lasting effects of personalized theta burst stimulation (TBS), a repetitive form of transcranial magnetic stimulation (TMS), ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451902224002064

The Neurophysiological Effects of Theta Burst Stimulation ...

In this systematic review, we summarize the electrophysiological effects of a single session of TBS measured with EEG and concurrent TMS-EEG in nonclinical ...

5.

link.springer.com

link.springer.com/article/10.1007/s00429-023-02634-x

A systematic review of the neurobiological effects of theta- ...

Theta burst stimulation (TBS) is associated with the modulation of a range of clinical, cognitive, and behavioural outcomes, but specific ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3260517/

Safety of Theta Burst Transcranial Magnetic Stimulation

Based on this review, TBS appears to be a safe and efficacious technique. However, given its novelty, it should be applied with caution.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0006322308013188

Theta Burst Stimulation of the Prefrontal Cortex

Thus, the present study explores whether TBS is safe particularly in terms of effects on cognition, mood, and electroencephalogram (EEG) measures in healthy ...

8.

biologicalpsychiatryjournal.com

biologicalpsychiatryjournal.com/article/S0006-3223(08)01318-8/abstract

Theta Burst Stimulation of the Prefrontal Cortex

Although TBS protocols of the human prefrontal cortex seem to be safe in healthy subjects, future studies need to address the occurrence of vagal reactions.

9.

nature.com

nature.com/articles/s41597-022-01820-6

Neuromodulatory effects of theta burst stimulation to the ...

Theta burst stimulation of the prefrontal cortex: safety and impact on cognition, mood, and resting electroencephalogram. Biological ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/19070834/

Theta burst stimulation of the prefrontal cortex: safety and ...

The present study explores whether TBS is safe particularly in terms of effects on cognition, mood, and electroencephalogram (EEG) measures in healthy subjects.