Healthy AdultNCT06750614
Exploring the Modulatory Role of Brain State on the Prefrontal Response to Excitatory Stimulation
A study testing intermittent theta-burst stimulation (iTBS) in people with Healthy Adult, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- intermittent theta-burst stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Dec 2024to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65
- Biological and mental health, based on a clinical interview
- Able to understand and follow instructions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Adult
- Being tested
- intermittent theta-burst stimulation (iTBS)
- Keywords
- Intermittent Theta-burst Stimulation, iTBS, Brain State, Transcranial Magnetic Stimulation, TMS, Functional Near-infrared Spectroscopy (fNIRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mood | Active comparator | During concurrent iTBS/fNIRS, stimuli with positive, negative, and neutral valence will be presented to participants to induce the corresponding mood. Receives: 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. Receives: Device: intermittent theta-burst stimulation (iTBS) |
| Relax | Active comparator | During concurrent iTBS/fNIRS, participants will be instructed to relax. Receives: Device: intermittent theta-burst stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenated hemoglobin (HbO) change
iTBS-induced HbO change in the DLPFC measured by fNIRS
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Deoxygenated hemoglobin (HbR) change
iTBS-induced HbR change in the DLPFC measured by fNIRS
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start3 Dec 2024
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Georg Kranz, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750614
- Sponsor's protocol ID
- HSEARS20230324002
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Assessment of the Modulatory Role of Brain State on the Prefrontal Response to Excitatory Stimulation: a Concurrent rTMS/fNIRS Pilot Study
- ClinicalTrials.gov ID
- NCT06750614
- Acronym / sponsor ID
- HSEARS20230324002
- Conditions
- Healthy Adult
- Keywords
- Intermittent Theta-burst Stimulation, iTBS, Brain State, Transcranial Magnetic Stimulation, TMS, Functional Near-infrared Spectroscopy (fNIRS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mood | Active comparator | Device: intermittent theta-burst stimulation (iTBS)During concurrent iTBS/fNIRS, stimuli with positive, negative, and neutral valence will be presented to participants to induce the corresponding mood. |
| Cognitive Task | Active comparator | Device: intermittent theta-burst stimulation (iTBS)During concurrent iTBS/fNIRS, the effects of participants' cognitive load will be assessed by performing the backward counting task. |
| Relax | Active comparator | Device: intermittent theta-burst stimulation (iTBS)During concurrent iTBS/fNIRS, participants will be instructed to relax. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 65
- Biological and mental health, based on a clinical interview
- Able to understand and follow instructions
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Cognitive Task, Mood, Relax |
Primary outcome
Oxygenated hemoglobin (HbO) change
Time frame: Through study completion, an average of 1 year
iTBS-induced HbO change in the DLPFC measured by fNIRS
1 secondary outcome
Deoxygenated hemoglobin (HbR) change
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent theta-burst stimulation (iTBS) in people with Healthy Adult, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenated hemoglobin (HbO) change (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.