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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06104462
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
6
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intermittent theta burst stimulation (iTBS)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Exploring the Cortical Hemodynamic Variability of Prefrontal iTBS: a Concurrent TBS/fNIRS Study
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cortical hemodynamic variability of iTBS and its courses

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.

Device: Intermittent theta burst stimulation (iTBS)
The iTBS protocol consists of 20 trains of stimulation. Each train comprises ten 3-pulse bursts, delivered at an intra-burst frequency of 50 Hz, with a 5 Hz overall frequency, followed by 8 seconds of rest. A total of 600 pulses (10*3*20) will be administered in this 3-minute iTBS protocol. Concurrent TBS/fNIRS stimulation will be applied over the left DLPFC at an intensity of 90% of the resting motor threshold (RMT), which is considered appropriate to ensure compliance and elicit robust DLPFC activation. Considering that the fNIRS optode beneath the coil increases the distance between the TMS coil and the skull by 10 mm, we will use the equation AdjMT% = MT + 2.8 * (Dsitex - Dm1). Therefore, 2.8 * 10 = 28% will be added to the normal intensity. The stimulation site over the DLPFC will be determined by the MNI coordinate (x-38, y+44, z+26) reported in previous studies.
Other Names:
  • Repetitive transcranial magnetic stimulation (rTMS)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Hong Kong Polytechnic University Hong Kong Hong Kong

    Sponsors and Collaborators

    • The Hong Kong Polytechnic University

    Investigators

    • Principal Investigator: Georg Kranz, PhD, The Hong Kong Polytechnic University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Georg Kranz, Assistant Professor, The Hong Kong Polytechnic University
    ClinicalTrials.gov Identifier:
    NCT06104462
    Other Study ID Numbers:
    • HSEARS20220812002-02
    First Posted:
    Oct 27, 2023
    Last Update Posted:
    Oct 27, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 27, 2023