HealthyNCT05427552
Exploring the Cortical Hemodynamic Response of Excitatory Brain Stimulation: a Pilot Study
A study testing Intermittent theta-burst stimulation (iTBS) in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Intermittent theta-burst stimulation (iTBS) is a promising treatment for major depressive disorder. However, fewer than 50% of patients show sufficient response. Therefore, the optimal treatment protocol is worth investigating. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 24 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 31 Aug 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed
Who cannot join
- history of epilepsy, seizures, or convulsions
- current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
- current or past diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
- with metal implants, such as a cochlear implant, neurostimulator, or cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Intermittent theta-burst stimulation (iTBS) is a promising treatment for major depressive disorder. However, fewer than 50% of patients show sufficient response. Therefore, the optimal treatment protocol is worth investigating. Recent studies show that the relationship between stimulation intensity and prefrontal hemodynamic response is not linear but in an inverse U-shape by exploring the hemodynamic changes before and after iTBS. Concurrent transcranial magnetic stimulation (TMS)/functional near-infrared spectroscopy (fNIRS) setup allows the investigators to observe the prefrontal hemodynamic response during stimulation.
The aim of this study is to investigate the effects of different intensities on brain activity during and after the stimulation using fNIRS.
Read the detailed description
Please refer to the full proposal
- Conditions
- Healthy
- Being tested
- Intermittent theta-burst stimulation (iTBS)
- Keywords
- Theta-Burst stimulation (iTBS), Functional near-infrared spectroscopy (fNIRS), Concurrent TMS/fNIRS, Prefrontal hemodynamic response
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
Also called Transcranial magnetic stimulation (TMS)
The iTBS will be applied over lDLPFC with three different intensities. The investigators put the NIRS probe under the TMS coil to detect the hemodynamic signal simultaneously, and the applied rMT was adjusted based on Stokes et al., 2007. The equation is AdjMT% = MT + 2.8 * (Dsitex - Dm1), and the thickness of the probe is 6mm, therefore, 2.8*6=16.8(%) were added to the normal intensity.
| Study group | Role | What they receive |
|---|---|---|
| Prefrontal hemodynamic response to 50% rMT iTBS | Experimental | Participants will receive 50% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS. Receives: Device: Intermittent theta-burst stimulation (iTBS) |
| Prefrontal hemodynamic response to 70% rMT iTBS | Experimental | Participants will receive 70% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS. Receives: Device: Intermittent theta-burst stimulation (iTBS) |
| Prefrontal hemodynamic response to 90% rMT iTBS | Experimental | Participants will receive 90% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS. 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 compared to baseline
iTBS-induced HbO change in the DLPFC before, during and after stimulation
Measured: During and post TBS-fNIRS measurement, up to 3 months
Secondary outcomes (2)
Deoxygenated hemoglobin (HbR) Change compared to baseline
iTBS-induced HbR change in the DLPFC before, during and after stimulation
Measured: During and post TBS-fNIRS measurement, up to 3 months
Oxygen saturation change compared to baseline
iTBS-induced oxygen saturation change in the DLPFC before, during and after stimulation
Measured: During and post TBS-fNIRS measurement, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Healthy volunteers will receive iTBS three times with three different intensities separated by one week to investigate the prefrontal hemodynamic response to different stimulation intensities.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 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
- Investigators
- Georg S Kranz, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427552
- Sponsor's protocol ID
- HSEARS20200120005-01
- Status last verified
- Sep 2022
- First submitted
- 16 Jun 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- 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 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Cortical Hemodynamic Response of Excitatory Brain Stimulation: a Pilot Study
- ClinicalTrials.gov ID
- NCT05427552
- Acronym / sponsor ID
- HSEARS20200120005-01
- Conditions
- Healthy
- Keywords
- Theta-Burst stimulation (iTBS), Functional near-infrared spectroscopy (fNIRS), Concurrent TMS/fNIRS, Prefrontal hemodynamic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 22 Jun 2022 (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.
Intermittent theta-burst stimulation (iTBS) is a promising treatment for major depressive disorder. However, fewer than 50% of patients show sufficient response. Therefore, the optimal treatment protocol is worth investigating. Recent studies show that the relationship between stimulation intensity and prefrontal hemodynamic response is not linear but in an inverse U-shape by exploring the hemodynamic changes before and after iTBS. Concurrent transcranial magnetic stimulation (TMS)/functional near-infrared spectroscopy (fNIRS) setup allows the investigators to observe the prefrontal hemodynamic response during stimulation.
The aim of this study is to investigate the effects of different intensities on brain activity during and after the stimulation using fNIRS.
Detailed description
Please refer to the full proposal
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Healthy volunteers will receive iTBS three times with three different intensities separated by one week to investigate the prefrontal hemodynamic response to different stimulation intensities.
| Arm | Type | Receives |
|---|---|---|
| Prefrontal hemodynamic response to 50% rMT iTBS | Experimental | Device: Intermittent theta-burst stimulation (iTBS)Participants will receive 50% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS. |
| Prefrontal hemodynamic response to 70% rMT iTBS | Experimental | Device: Intermittent theta-burst stimulation (iTBS)Participants will receive 70% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS. |
| Prefrontal hemodynamic response to 90% rMT iTBS | Experimental | Device: Intermittent theta-burst stimulation (iTBS)Participants will receive 90% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Right-handed
Key exclusion criteria (4 listed)
- history of epilepsy, seizures, or convulsions
- current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
- current or past diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
- with metal implants, such as a cochlear implant, neurostimulator, or cardiac pacemaker
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)Also: Transcranial magnetic stimulation (TMS)The iTBS will be applied over lDLPFC with three different intensities. The investigators put the NIRS probe under the TMS coil to detect the hemodynamic signal simultaneously, and the applied rMT was adjusted based on Stokes et al., 2007. The equation is AdjMT% = MT + 2.8 * (Dsitex - Dm1), and the thickness of the probe is 6mm, therefore, 2.8*6=16.8(%) were added to the normal intensity. | Device | Prefrontal hemodynamic response to 50% rMT iTBS, Prefrontal hemodynamic response to 70% rMT iTBS, Prefrontal hemodynamic response to 90% rMT iTBS |
Primary outcome
Oxygenated hemoglobin (HbO) change compared to baseline
Time frame: During and post TBS-fNIRS measurement, up to 3 months
iTBS-induced HbO change in the DLPFC before, during and after stimulation
2 secondary outcomes
Deoxygenated hemoglobin (HbR) Change compared to baseline
Time frame: During and post TBS-fNIRS measurement, up to 3 months
Oxygen saturation change compared to baseline
Time frame: During and post TBS-fNIRS measurement, up to 3 months
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 15 Sep 2022.
- 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.
Georg S Kranz, PhD principal investigator
The Hong Kong Polytechnic University
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, 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 1 inclusion and 4 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 15 Sep 2022. 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 compared to baseline (time frame: During and post TBS-fNIRS measurement, up to 3 months). 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 15 Sep 2022.