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

Recruiting

• Conditions: Healthy Adults

• Registration Number: NCT06902571
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-30
• Study Start: 2025-04-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• healthiness based on history and psychiatric assessment

Exclusion Criteria

• a medical history of a major systemic illness or a neurological or psychiatric disorder
• pregnancy
• common fNIRS, MRI and TMS exclusion criteria such as a history of brain surgery, head injury, cardiac pacemaker, intracranial metallic particles or a history of seizures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baseline	Before, during and after iTBS stimulation, up to 15 minutes	iTBS-induced HbO and HbR change in the DLPFC before, during and after stimulation
BOLD signals	Before, during and after iTBS stimulation, up to 15 minutes	iTBS-induced BOLD change in the DLPFC before, during and after stimulation

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hung Hom, Hong Kong