Clinical trial NCT06976879: Intra- and Interindividual Moderators of Prefrontal Excitability Investigated Using Simultaneous TMS With Neuroimaging
Official title: Intra- and Interindividual Moderators of Prefrontal Excitability Investigated Using Simultaneous TMS With Neuroimaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Adults
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

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.


Eligibility criteria: Inclusion Criteria:

* consider yourself healthy in general and aged 18-60

Exclusion Criteria:

* 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.

Primary outcomes:
measure: BOLD signals
timeFrame: 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:
measure: Age
timeFrame: visit 1
measure: Gender
timeFrame: visit 1
measure: Caffeine consumption
timeFrame: Before stimulation on visit 2 and visit 3
measure: Mood states
timeFrame: Before stimulation on visit 2 and visit 3
measure: Physical activity
timeFrame: Before stimulation on visit 2 and visit 3
measure: Sleep quality
timeFrame: Before stimulation on visit 2 and visit 3
measure: Time of the experiment
timeFrame: Before stimulation on visit 2 and visit 3
measure: Working Memory
timeFrame: After stimulation on visit 2 and visit 3
measure: Vigilance
timeFrame: After stimulation on visit 2 and visit 3
measure: Attention
timeFrame: After stimulation on visit 2 and visit 3
measure: Childhood maltreatment
timeFrame: Visit 1
measure: Family history in first-degree relatives
timeFrame: Visit 1
measure: Marital status
timeFrame: Visit 1
measure: Handedness
timeFrame: Visit 1
measure: Education years
timeFrame: Visit 1
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Georg S Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
References: