Exploring the Modulatory Role of Brain State on the Prefrontal Response to Excitatory Stimulation

April 28, 2026 updated by: Dr Georg Kranz, The Hong Kong Polytechnic University

Systematic Assessment of the Modulatory Role of Brain State on the Prefrontal Response to Excitatory Stimulation: a Concurrent rTMS/fNIRS Pilot Study

Therapeutic repetitive transcranial magnetic stimulation (rTMS) for depression is well-supported, with multiple protocols approved by the United States Food and Drug Administration and global efforts aimed at boosting its antidepressant effects underway. However, there exists an under-reported aspect of clinical trials using rTMS: what are patients doing during each stimulation session? Here, the investigators begin this investigation with individuals without a history of depression nor other psychiatric diagnosis. The investigators focus on the underlying brain activity. The investigators will systematically assess the modulatory role of brain state on the brain's response to a session of rTMS by using a concurrent, non-invasive brain imaging setting: functional near-infrared spectroscopy (fNIRS), marking the first effort of its kind in this field.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The scientific literature on rTMS rehabilitation is steadily growing and new treatment protocols that aim to optimize rehabilitation efficacy as well as efficiency are emerging. However, no consideration to what patients should be doing during rTMS treatment sessions is given. These details are typically omitted in the literature, and advice is not given in recent guidelines. When details are reported, patients are assumed to enter a relaxed state during treatment. This assumption is highly problematic, especially for MDD because depression is an internalizing disorder, wherein emotional and cognitive dyscontrol are major features linked with abnormal activity of the dorsolateral prefrontal cortex (DLPFC), the region being stimulated. Indeed, instructing patients to concentrate on thoughts that exacerbate their depressive symptoms during stimulation diminishes the antidepressant treatment effect, and cognitive neuroscience research suggests the importance of considering the initial brain state when conducting behavioral and neuroimaging experiments with TMS. Attention to what occurs during stimulation is highly relevant but usually omitted in neuropsychiatric rehabilitation research. This proposal is a systematic assessment of the modulatory role of brain state on the prefrontal response to rTMS in healthy participants. Results from this study will inform whether the clinical literature on therapeutic rTMS is mistaken for not controlling for brain state, and provide proof-of-concept for future clinical trials and collaborative research proposals (CRF) for the treatment of neuropsychiatric disorders.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18 to 65
  • Biological and mental health, based on a clinical interview
  • Able to understand and follow instructions

Exclusion Criteria:

  • Major internal diseases, neurological disorders, or mental disorders
  • Having a metal implant
  • Hearing problems or in-ear ringing
  • Pregnancy or breastfeeding
  • Any conditions that will contraindicate to iTBS or fNIRS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive Task
During concurrent iTBS/fNIRS, the effects of participants' cognitive load will be assessed by performing the backward counting task.
Device: intermittent theta-burst stimulation (iTBS)
In each visit, the intensity of the iTBS applied to the participant will be set at 70% of their individual resting motor threshold (rMT), with one session specifically targeting the left DLPFC.
Active Comparator: Relax
During concurrent iTBS/fNIRS, participants will be instructed to relax.
Device: intermittent theta-burst stimulation (iTBS)
In each visit, the intensity of the iTBS applied to the participant will be set at 70% of their individual resting motor threshold (rMT), with one session specifically targeting the left DLPFC.
Active Comparator: Mood
During concurrent iTBS/fNIRS, stimuli with positive, negative, and neutral valence will be presented to participants to induce the corresponding mood.
Device: intermittent theta-burst stimulation (iTBS)
In each visit, the intensity of the iTBS applied to the participant will be set at 70% of their individual resting motor threshold (rMT), with one session specifically targeting the left DLPFC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenated hemoglobin (HbO) change
Time Frame: Through study completion, an average of 1 year
iTBS-induced HbO change in the DLPFC measured by fNIRS
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deoxygenated hemoglobin (HbR) change
Time Frame: Through study completion, an average of 1 year
iTBS-induced HbR change in the DLPFC measured by fNIRS
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Actual)

December 5, 2025

Study Completion (Actual)

December 5, 2025

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSEARS20230324002

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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