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

NCT05427565 | Completed

• 1 other identifier: HSEARS20200120005-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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)

Conditions

Healthy

Keywords

Theta-Burst stimulation (iTBS); Functional near-infrared spectroscopy (fNIRS); Concurrent TMS/fNIRS; Prefrontal hemodynamic response; Longitudinal effects

Outcome Measures

Primary Outcomes (1)

• Oxygenated hemoglobin (HbO) change compared to baseline

  iTBS-induced HbO change in the DLPFC before, during and after stimulation

  During and post TBS-fNIRS measurement, up to 1 month

Secondary Outcomes (2)

• Deoxygenated hemoglobin (HbR) change compared to baseline

  During and post TBS-fNIRS measurement, up to 1 month

• Oxygen saturation change compared to baseline

  During and post TBS-fNIRS measurement, up to 1 month

Study Arms (1)

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.

Other: caffeine; Other: Experimental time

Interventions

caffeine OTHER

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

Cortical hemodynamic variability of four weeks iTBS

Experimental time OTHER

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

Cortical hemodynamic variability of four weeks iTBS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-handed

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Georg S Kranz, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: August 15, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-08

Locations

HK (1)