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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adults
• Intervention / Treatment: Device: Intermittent theta burst stimulation (iTBS)

• Study Type: Observational
• Enrollment (Estimated): 5

Contacts and Locations

• Study Contact: Name: Georg S. Kranz, PhD; Phone Number: 27664838; Email: georg.kranz@polyu.edu.hk

Study Locations

• Hong Kong
  • Hung Hom
    • Hong Kong, Hung Hom, Hong Kong
      • Recruiting
      • The Hong Kong Polytechnic University
      • Contact: Georg S. Kranz, PhD; Phone Number: 27664838; Email: georg.kranz@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy group; A group of healthy adults shall undergo concurrent iTBS/fNIRS/fMRI measurements	Device: Intermittent 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Georg S. Kranz, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HSEARS20231218001-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No