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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: caffeine; Other: Experimental time

• Registration Number: NCT05427565
• Lead Sponsor: The Hong Kong Polytechnic University

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)

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 Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Status Verified: 2022-08
• Study Start: 2022-08-15
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cortical hemodynamic variability of four weeks iTBS	caffeine	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.
Cortical hemodynamic variability of four weeks iTBS	Experimental time	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong