Loading search results
Sponsor study identifier
observational
60
1 country
1
Study Start
May 21, 2024
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2024
Actual (reported)April 15, 2025
Actual (reported)May 16, 2025
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
A group of healthy adults shall undergo concurrent 5 Hz iTBS/fMRI measurements
A group of healthy adults shall undergo concurrent 2.5 Hz iTBS/fMRI measurements
Healthy adults
The Hong Kong Polytechnic University
Hong Kong, China
Georg S Kranz, PhD
The Hong Kong Polytechnic University
First Submitted
April 15, 2025
First Posted
May 16, 2025
Study Start
May 21, 2024
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 16, 2025
Record last verified: 2025-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: