NCT06104462

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

October 20, 2023

Last Update Submit

September 13, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 3 months

Secondary Outcomes (2)

  • Deoxygenated hemoglobin (HbR) change compared to baseline

    During and post TBS-fNIRS measurement, up to 3 months

  • Oxygen saturation change compared to baseline

    During and post TBS-fNIRS measurement, up to 3 months

Study Arms (1)

Cortical hemodynamic variability of iTBS and its courses

EXPERIMENTAL

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)

Interventions

Intermittent theta burst stimulation (iTBS)DEVICE

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.

Also known as: Repetitive transcranial magnetic stimulation (rTMS)
Cortical hemodynamic variability of iTBS and its courses

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Georg Kranz, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georg Kranz, PhD

CONTACT

2766georg.kranz@polyu.edu.hk

Weili Xia, MSc

CONTACT

92859726weili-adam.xia@connect.polyu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 27, 2023

Study Start

October 18, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

IPD may be shared upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Upon request
Access Criteria
Upon request

Locations

HK(1)