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

Overview

This study will investigate the effect of caffeine and time of day on brain excitability using excitatory brain stimulation. We 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)

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2022

Detailed Description

Please refer to the full protocol.

Interventions

  • Other: caffeine
    • We 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
    • We will ask participant to attend the experiment in the morning or afternoon

Arms, Groups and Cohorts

  • Experimental: Cortical hemodynamic variability of four weeks iTBS
    • One healthy participant will be included in our 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Deoxygenated hemoglobin (HbR) 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
  • Oxygen saturation 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Hong Kong Polytechnic University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Georg Kranz, Assistant Professor – The Hong Kong Polytechnic University
  • Overall Official(s)
    • Georg S Kranz, PhD, Principal Investigator, The Hong Kong Polytechnic University
  • Overall Contact(s)
    • Georg S Kranz, PhD, 2766, georg.kranz@polyu.edu.hk

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