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NCT Number: NCT06902571

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hong Kong Polytechnic University

Hong Kong, Hung Hom

Location status: Recruiting

Location contact

Georg S. Kranz, PhD

CONTACT

[email protected]

27664838

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Before, during and after iTBS stimulation, up to 15 minutes

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

  2. BOLD signals

    Time frame: Before, during and after iTBS stimulation, up to 15 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Georg S. Kranz, PhD

CONTACT

[email protected]

27664838

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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