Cross-validating the iTBS-induced Hemodynamic Response From fNIRS and fMRI: a Concurrent iTBS-fMRI-fNIRS Study

NCT06902571 | Recruiting

• 1 other identifier: HSEARS20231218001-03
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) is well established in treating patients with major depressive disorder (MDD). However, the iTBS-induced hemodynamic response during or immediately after a full session of stimulation has not been fully investigated. Although several concurrent iTBS/functional Near Infrared Spectroscopy (fNIRS) and iTBS/functional magnetic resonance imaging (fMRI) studies have investigated the hemodynamic response during or immediately after left DLPFC iTBS, they revealed inconsistent findings in the stimulated DLPFC. Given that the variability in iTBS-induced hemodynamic response in the stimulated DLPFC could be modulated by various inter- and intra-individual factors, cross-validating the findings from both techniques (fNIRS and fMRI) in the same group of participants under the same conditions through a simultaneous fMRI/fNIRS setting enables a straightforward comparison and interpretation of results from each technique. However, to our knowledge, cross-validation of iTBS-related fNIRS and simultaneous fMRI data has not been conducted yet, even the implementation of a simultaneous iTBS/fMRI/fNIRS setup is technically feasible with the mutually compatible equipment. Therefore, the current study has two primary objectives: Firstly, to establish a novel and practical methodological pipeline for simultaneously conducting iTBS/fMRI/fNIRS. Secondly, to cross-validate the hemodynamic responses during and immediately after iTBS, respectively monitored by fNIRS and fMRI.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baseline

  iTBS-induced HbO and HbR change in the DLPFC before, during and after stimulation

  Before, during and after iTBS stimulation, up to 15 minutes

• BOLD signals

  iTBS-induced BOLD change in the DLPFC before, during and after stimulation

  Before, during and after iTBS stimulation, up to 15 minutes

Study Arms (1)

Healthy group

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

Device: Intermittent theta burst stimulation (iTBS)

Interventions

Intermittent theta burst stimulation (iTBS) DEVICE

600 pulses (3 pulses × 10 bursts × 20 trains = 600 pulses) will be delivered each session with reference to a 3-minute protocol developed by Huang, et al. (2005). Before, during and after iTBS, both fNIRS and fMRI measurements will be conducted simultaneously.

Healthy group

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:

• healthiness based on history and psychiatric assessment

You may not qualify if:

• a medical history of a major systemic illness or a neurological or psychiatric disorder
• pregnancy

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hung Hom, Hong Kong

RECRUITING

Study Officials

• Georg S. Kranz

  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: March 24, 2025
• First Posted: March 30, 2025
• Study Start: April 22, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)