Intra- and Interindividual Moderators of Prefrontal Excitability Investigated Using Simultaneous TMS With Neuroimaging

NCT06976879 | Recruiting

• 1 other identifier: HSEARS20231218001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The simultaneous application of brain stimulation and neuroimaging offers significant potential for advancing basic neuroscience research and developing objective diagnostic and prognostic markers for mental disorders. The University Research Facility in Behavioral and Systems Neuroscience (UBSN), in collaboration with Principal Investigator Dr. Georg Kranz, recently acquired a TMS-compatible Magnetic Resonance Imaging (MRI) radio-frequency head coil. This cutting-edge equipment, developed by Dr. Martin Tik's research lab in Vienna, enables detailed mapping of both local and remote neural effects of intermittent theta-burst stimulation (iTBS)-a non-pharmacological treatment with proven efficacy for mental disorders. The upgraded setup addresses limitations of older concurrent TMS-fMRI systems, which struggled with image quality and practical applicability. The new system incorporates a multi-channel receiver array, allowing for high-resolution imaging at a fast rate. In this design, the TMS coil is positioned outside the imaging coil, with stimulation pulses passing through the thin imaging coil to reach the participant's brain and induce targeted neural changes. This advanced system enables the investigation of therapeutic network changes induced by iTBS by capturing acute brain responses during stimulation. Additionally, its sensitivity allows for dose-response assessments at the individual subject level. To leverage these advancements, pilot studies utilizing concurrent rTMS/fMRI are proposed to investigate intra- and interindividual moderators of therapeutic brain stimulation. The iTBS/fMRI study will focus on stimulation-induced hemodynamic changes in key subcortical structures and networks that mediate therapeutic responses to iTBS. Specifically, the study aims to examine changes in central limbic regions, including the subgenual anterior cingulate cortex (sgACC), anterior insula, amygdala, ventromedial prefrontal cortex, and orbitofrontal cortex. By exploring these regions, the mechanisms underlying the therapeutic effects of rTMS can be elucidated, providing a comprehensive understanding of how acute brain responses translate into clinical outcomes. This approach represents a significant step forward in advancing the understanding of iTBS, with the potential to refine and optimize this treatment for mental disorders.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• BOLD signals

  This repeated-measures study involves two participant groups. Each participant will attend one screening (visit 1) and two experimental visits (visits 2 and 3), with at least a 48-hour washout period between experimental visits. One group will receive active iTBS and the other active control iTBS during both experimental visits. We will assess iTBS-induced BOLD signal changes in the DLPFC and other brain regions (before, during, and after stimulation) and investigate modulation by interpersonal and day-to-day intrapersonal factors.

  Before stimulation (3-5 minutes), during stimulation (3-5 minutes), and post-stimulation (up to 15 minutes after iTBS completion) on visit 2 and visit 3

Secondary Outcomes (15)

• Age

  visit 1

• Gender

  visit 1

• Caffeine consumption

  Before stimulation on visit 2 and visit 3

• Mood states

  Before stimulation on visit 2 and visit 3

• Physical activity

  Before stimulation on visit 2 and visit 3

Study Arms (2)

Healthy experimental group

A group of healthy adults shall undergo concurrent 5 Hz iTBS/fMRI measurements

Active control group

A group of healthy adults shall undergo concurrent 2.5 Hz iTBS/fMRI measurements

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

You may qualify if:

• consider yourself healthy in general and aged 18-60

You may not qualify if:

• current internal illness;
• current or former psychiatric or neurological illness;
• current or former alcohol or substance abuse;
• current or previous use of any psychotropic medication;
• current or previous use of any illicit drug;
• any ferromagnetic metal in your body;
• known or possible pregnancy, including the situation when the first day of a
• female's last menstrual period was more than 28 days ago; or
• any contraindication to TMS as assessed by Rossi et al.'s (2011) screening questionnaire.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

Study Officials

• Georg S Kranz, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georg S Kranz, PhD

CONTACT

27664838; georg.kranz@polyu.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 16, 2025
• Study Start: May 21, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)