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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06902571
Enrollment
13
Registered
2025-03-30
Start date
2025-04-22
Completion date
2025-12-31
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

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.

Interventions

DEVICEIntermittent theta burst stimulation (iTBS)

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baselineBefore, during and after iTBS stimulation, up to 15 minutesiTBS-induced HbO and HbR change in the DLPFC before, during and after stimulation
BOLD signalsBefore, during and after iTBS stimulation, up to 15 minutesiTBS-induced BOLD change in the DLPFC before, during and after stimulation

Countries

Hong Kong

Contacts

PRINCIPAL_INVESTIGATORGeorg S. Kranz

The Hong Kong Polytechnic University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026