Exploring the Cortical Hemodynamic Variability of Four Weeks iTBS on a Healthy Participant: a Case Study

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05427565

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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 stimulation. Moreover, the experiment will be conducted at different times of the day (morning or afternoon)

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: caffeine Other: Experimental time	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

One healthy participant will undergo four weeks of concurrent TBS/fNIRS to investigate the cortical hemodynamic variabilityOne healthy participant will undergo four weeks of concurrent TBS/fNIRS to investigate the cortical hemodynamic variability

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Exploring the Cortical Hemodynamic Variability of Four Weeks iTBS on a Healthy Participant: a Case Study

Actual Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Sep 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cortical hemodynamic variability of four weeks iTBS 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.	Other: caffeine 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 Other: Experimental time The investigators will ask participant to attend the experiment in the morning or afternoon

Arm

Intervention/Treatment

Experimental: Cortical hemodynamic variability of four weeks iTBS

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.

Other: caffeine

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

Other: Experimental time

The investigators will ask participant to attend the experiment in the morning or afternoon

Outcome Measures

Primary Outcome Measures

Oxygenated hemoglobin (HbO) change compared to baseline [During and post TBS-fNIRS measurement, up to 1 month]
iTBS-induced HbO change in the DLPFC before, during and after stimulation

Secondary Outcome Measures

Deoxygenated hemoglobin (HbR) change compared to baseline [During and post TBS-fNIRS measurement, up to 1 month]
iTBS-induced HbO change in the DLPFC before, during and after stimulation
Oxygen saturation change compared to baseline [During and post TBS-fNIRS measurement, up to 1 month]
iTBS-induced HbO change in the DLPFC before, during and after stimulation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Right-handed

Exclusion Criteria:

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