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NCT05427565 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05427565
Other study ID # HSEARS20200120005-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2022
Est. completion date September 9, 2022

Study information
Verified date August 2022
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date September 9, 2022
Est. primary completion date September 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Hong Kong The Hong Kong Polytechnic University Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Deoxygenated hemoglobin (HbR) 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 Oxygen saturation 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
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