Exploring the Cortical Hemodynamic Variability of Prefrontal iTBS: a Concurrent TBS/fNIRS Study

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Device: Intermittent theta burst stimulation (iTBS)

• Registration Number: NCT06104462
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

An increasing number of studies have used the intermittent theta-burst stimulation (iTBS) protocol to investigate neural plasticity non-invasively in the prefontal cortex in healthy humans and in patients with psychiatric disorders. However, the variability in the neurophysiological response to iTBS stimulation is high. The cause of this variability is multifactorial and to some degree still unknown. Therefore, the current study explores inter- and intra-individual factors that are potentially moderating iTBS-induced excitability changes. A greater understanding of these determinants would be highly valuable for optimizing the therapeutic application of iTBS.

Detailed Description

The investigators will measure the cortical excitability induced by iTBS with concurrent TBS/fNIRS technique in the same healthy individuals on multiple testing days. Meanwhile, several potential inter- (age, gender, etc.) and intra-individual factors (daily mood, daily physical activity levels, etc.) recently identified in non-invasive transcranial brain stimulation studies will be assessed before applying iTBS to the same individual on each testing day.

Study Timeline

• Study Start: 2023-10-18
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-10-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• healthiness based on history and psychiatric assessment
• being able to hear and understand the verbal instructions
• completed at least 6 years of formal education

Exclusion Criteria

• a current or past diagnosis of psychiatric, neurological disorders, or severe internal illness
• any conditions that will contraindicate to iTBS or fNIRS
• psychiatric disorders in their first-degree relatives
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cortical hemodynamic variability of iTBS and its courses	Intermittent theta burst stimulation (iTBS)	A group of healthy adults shall undergo repeated experimental visits with concurrent TBS/fNIRS (3≤repetition≤15). An interval of at least two days (48 hours) between the visits is required to minimize carry-over effects from the iTBS protocols. Inter- (age, gender, personality inventory, etc.) and intra-individual factors (daily mood, daily sleep quality, physical activity levels, etc.) that are potentially moderating iTBS-induced excitability changes will be explored.

Primary Outcome Measures

Name	Time	Method
Oxygenated hemoglobin (HbO) change compared to baseline	During and post TBS-fNIRS measurement, up to 3 months	iTBS-induced HbO change in the DLPFC before, during and after stimulation

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation change compared to baseline	During and post TBS-fNIRS measurement, up to 3 months	iTBS-induced oxygen saturation change in the DLPFC before, during and after stimulation
Deoxygenated hemoglobin (HbR) change compared to baseline	During and post TBS-fNIRS measurement, up to 3 months	iTBS-induced HbR change in the DLPFC before, during and after stimulation

Trial Locations

Locations (1)

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