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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Healthy

Treatments: Device: Intermittent theta burst stimulation (iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06104462

HSEARS20220812002-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Cortical hemodynamic variability of iTBS and its courses

Experimental group

Description:

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.

Treatment:

Device: Intermittent theta burst stimulation (iTBS)