HealthyNCT05427565
Exploring the Cortical Hemodynamic Variability of Four Weeks iTBS on a Healthy Participant: a Case Study
A study testing caffeine and Experimental time in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study will investigate the effect of caffeine and time of day on brain excitability using excitatory brain stimulation. The investigators will recruit a healthy participant and conduct a concurrent iTBS/fNIRS protocol for 20 consecutive sessions over four weeks with or without caffeine consumption before the… 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?
- caffeine and Experimental time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Aug 2022to 9 Sep 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
This study will investigate the effect of caffeine and time of day on brain excitability using excitatory brain stimulation. The investigators will recruit a healthy participant and conduct a concurrent iTBS/fNIRS protocol for 20 consecutive sessions over four weeks with or without caffeine consumption before the stimulation. Moreover, the experiment will be conducted at different times of the day (morning or afternoon)
Read the detailed description
One healthy participant will be recruited for this study. The participants will be subjected to concurrent TBS/fNIRS, to which the iTBS will be applied on the left DLPFC and the NIRS will measure the prefrontal hemodynamic response simultaneously.
- Conditions
- Healthy
- Being tested
- caffeine, Experimental time
- Keywords
- Theta-Burst stimulation (iTBS), Functional near-infrared spectroscopy (fNIRS), Concurrent TMS/fNIRS, Prefrontal hemodynamic response, Longitudinal effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeineOther
The investigators will ask participant to only intake 200 mg of caffeine one hour before the experiment (no other caffeine intake since the wake-up) or avoid caffeine intake at all before the experiment
Experimental timeOther
The investigators will ask participant to attend the experiment in the morning or afternoon
| Study group | Role | What they receive |
|---|---|---|
| Cortical hemodynamic variability of four weeks iTBS | Experimental | One healthy participant will be included in this study, which lasts for 4 weeks, 5 visits per week, involving 20 visits in total.
The participant will receive the following instructions the night before: to take 200 mg of caffeine one hour before the visit (no other caffeine intake since the wake-up) or avoid caffeine intake at all before the visit; to attend the visit in the morning or afternoon. These assignments will be randomized in a counterbalanced manner. Receives: Other: caffeine; Other: Experimental time |
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 1 month
Secondary outcomes (2)
Deoxygenated hemoglobin (HbR) 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 1 month
Oxygen saturation 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 1 month
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 start15 Aug 2022
- Primary completion9 Sep 2022
- Study completion9 Sep 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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- One healthy participant will undergo four weeks of concurrent TBS/fNIRS to investigate the cortical hemodynamic variability
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT05427565
- Sponsor's protocol ID
- HSEARS20200120005-02
- Status last verified
- Aug 2022
- First submitted
- 16 Jun 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Variability of Four Weeks iTBS on a Healthy Participant: a Case Study
- ClinicalTrials.gov ID
- NCT05427565
- Acronym / sponsor ID
- HSEARS20200120005-02
- Conditions
- Healthy
- Keywords
- Theta-Burst stimulation (iTBS), Functional near-infrared spectroscopy (fNIRS), Concurrent TMS/fNIRS, Prefrontal hemodynamic response, Longitudinal effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 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.
This study will investigate the effect of caffeine and time of day on brain excitability using excitatory brain stimulation. The investigators will recruit a healthy participant and conduct a concurrent iTBS/fNIRS protocol for 20 consecutive sessions over four weeks with or without caffeine consumption before the stimulation. Moreover, the experiment will be conducted at different times of the day (morning or afternoon)
Detailed description
One healthy participant will be recruited for this study. The participants will be subjected to concurrent TBS/fNIRS, to which the iTBS will be applied on the left DLPFC and the NIRS will measure the prefrontal hemodynamic response simultaneously.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One healthy participant will undergo four weeks of concurrent TBS/fNIRS to investigate the cortical hemodynamic variability
| Arm | Type | Receives |
|---|---|---|
| Cortical hemodynamic variability of four weeks iTBS | Experimental | Other: caffeine, Other: Experimental timeOne healthy participant will be included in this study, which lasts for 4 weeks, 5 visits per week, involving 20 visits in total. The participant will receive the following instructions the night before: to take 200 mg of caffeine one hour before the visit (no other caffeine intake since the wake-up) or avoid caffeine intake at all before the visit; to attend the visit in the morning or afternoon. These assignments will be randomized in a counterbalanced manner. |
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 |
|---|---|---|
| caffeineThe investigators will ask participant to only intake 200 mg of caffeine one hour before the experiment (no other caffeine intake since the wake-up) or avoid caffeine intake at all before the experiment | Other | Cortical hemodynamic variability of four weeks iTBS |
| Experimental timeThe investigators will ask participant to attend the experiment in the morning or afternoon | Other | Cortical hemodynamic variability of four weeks iTBS |
Primary outcome
Oxygenated hemoglobin (HbO) change compared to baseline
Time frame: During and post TBS-fNIRS measurement, up to 1 month
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 1 month
Oxygen saturation change compared to baseline
Time frame: During and post TBS-fNIRS measurement, up to 1 month
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.
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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 caffeine and Experimental time 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 1 month). 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.