- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433829
Prefrontal Neuroplasticity and Coping Strategies in Healthy Population
March 29, 2026 updated by: Dr Georg Kranz, The Hong Kong Polytechnic University
Prefrontal Neuroplasticity and Coping Strategies in Healthy Population: a Randomized Sham Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
42
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 Contact
- Name: Georg Kranz, PhD
- Phone Number: +85227664838
- Email: Georg.kranz@polyu.edu.hk
Study Locations
-
-
九龙
-
Hong Kong, 九龙, China
- Recruiting
- The Hong Kong Polytechnic University
-
Contact:
- Georg Kranz
- Phone Number: 27664838
- Email: Georg.kranz@polyu.edu.hk
-
-
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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-60 years old;
Exclusion Criteria:
- 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.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Real Stimulation
Participants in this arm will receive a real session of iTBS over the left dorsolateral prefrontal cortex
|
sham stimulation protocols is to mimic the sensations experienced by participants during active stimulation, without stimulating the brain
Other Names:
|
|
Sham Comparator: Sham Stimulation
Participants in this arm will receive a sham session of iTBS over the left dorsolateral prefrontal cortex
|
sham stimulation protocols is to mimic the sensations experienced by participants during active stimulation, without stimulating the brain
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
iTBS induced prefrontal cortex activity and connectivity
Time Frame: 3 minutes before, during, and after the stimulation
|
3 minutes before, during, and after the stimulation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
perceived stress scale
Time Frame: the same day before conducting the experiment
|
the same day before conducting the experiment
|
|
coping inventory for stressful situations
Time Frame: the same day before conducting the experiment
|
the same day before conducting the experiment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 17, 2026
Primary Completion (Estimated)
March 30, 2026
Study Completion (Estimated)
March 30, 2026
Study Registration Dates
First Submitted
February 19, 2026
First Submitted That Met QC Criteria
February 19, 2026
First Posted (Actual)
February 25, 2026
Study Record Updates
Last Update Posted (Actual)
April 2, 2026
Last Update Submitted That Met QC Criteria
March 29, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20230705001-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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