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

NCT06750614 | Completed DMC

• 1 other identifier: HSEARS20230324002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult

Keywords

Intermittent Theta-burst Stimulation, iTBS; Brain State; Transcranial Magnetic Stimulation, TMS; Functional Near-infrared Spectroscopy (fNIRS)

Outcome Measures

Primary Outcomes (1)

• Oxygenated hemoglobin (HbO) change

  iTBS-induced HbO change in the DLPFC measured by fNIRS

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Deoxygenated hemoglobin (HbR) change

  Through study completion, an average of 1 year

Study Arms (3)

Mood

ACTIVE COMPARATOR

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)

Cognitive Task

ACTIVE COMPARATOR

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)

Relax

ACTIVE COMPARATOR

During concurrent iTBS/fNIRS, participants will be instructed to relax.

Device: intermittent theta-burst stimulation (iTBS)

Interventions

intermittent theta-burst stimulation (iTBS) DEVICE

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.

Cognitive Task; Mood; Relax

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: December 3, 2024
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)