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Completed

NCT Number: NCT05427565

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

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Experimental time

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2022
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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