NCT07433829

Brief Summary

The current study serves as a pilot for the GRF project "Predicting illness trajectories in fully remitted major depression using concurrent TBS/fNIRS." The project examines whether intermittent theta-burst stimulation (iTBS) induces immediate changes in prefrontal excitability in healthy individuals, compared to sham stimulation. In this randomized, sham-controlled trial, investigators will assess several psychological measures-including the Perceived Stress Scale and the Coping Inventory for Stressful Situations-to explore how stress levels and coping strategies relate to immediate prefrontal cortex (PFC) activity changes following TBS.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

April 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

February 19, 2026

Last Update Submit

March 29, 2026

Conditions

Keywords

concurrent TMS/fNIRSprefrontal cortexstress

Outcome Measures

Primary Outcomes (1)

  • iTBS induced prefrontal cortex activity and connectivity

    3 minutes before, during, and after the stimulation

Secondary Outcomes (2)

  • perceived stress scale

    the same day before conducting the experiment

  • coping inventory for stressful situations

    the same day before conducting the experiment

Study Arms (2)

Real Stimulation

ACTIVE COMPARATOR

Participants in this arm will receive a real session of iTBS over the left dorsolateral prefrontal cortex

Device: Transcranial Magnetic Stimulation

Sham Stimulation

SHAM COMPARATOR

Participants in this arm will receive a sham session of iTBS over the left dorsolateral prefrontal cortex

Device: Transcranial Magnetic Stimulation

Interventions

sham stimulation protocols is to mimic the sensations experienced by participants during active stimulation, without stimulating the brain

Also known as: Transcranial Magnetic Stimulation Sham
Real StimulationSham Stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old;

You may not qualify if:

  • a family history of psychiatric disorders;
  • history of or currently diagnosed neuropsychiatric conditions;
  • history of or active systemic illnesses such as cancer, epilepsy, diabetes, hypertension, or other medical conditions;
  • contraindications to transcranial magnetic stimulation (TMS);
  • any prior exposure to brain stimulation procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 九龙, China

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

January 17, 2026

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

April 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations