CClinicalTrials.gg
CompletedNCT05427552Updated Sep 15, 2022

Exploring the Cortical Hemodynamic Response of Excitatory Brain Stimulation: a Pilot Study

An interventional study of Intermittent theta-burst stimulation (iTBS) in Healthy, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-15.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

Intermittent theta-burst stimulation (iTBS) is a promising treatment for major depressive disorder. However, fewer than 50% of patients show sufficient response. Therefore, the optimal treatment protocol is worth investigating. Recent studies show that the relationship between stimulation intensity and prefrontal hemodynamic response is not linear but in an inverse U-shape by exploring the hemodynamic changes before and after iTBS. Concurrent transcranial magnetic stimulation (TMS)/functional near-infrared spectroscopy (fNIRS) setup allows the investigators to observe the prefrontal hemodynamic response during stimulation.

The aim of this study is to investigate the effects of different intensities on brain activity during and after the stimulation using fNIRS.

Read the detailed description

Please refer to the full proposal

02

Conditions studied

  • Healthy

Keywords

  • Theta-Burst stimulation (iTBS)
  • Functional near-infrared spectroscopy (fNIRS)
  • Concurrent TMS/fNIRS
  • Prefrontal hemodynamic response
03

In context

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Right-handed

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Prefrontal hemodynamic response to 50% rMT iTBS

    Participants will receive 50% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS.

    Device: Intermittent theta-burst stimulation (iTBS)

  • Experimental
    Prefrontal hemodynamic response to 70% rMT iTBS

    Participants will receive 70% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS.

    Device: Intermittent theta-burst stimulation (iTBS)

  • Experimental
    Prefrontal hemodynamic response to 90% rMT iTBS

    Participants will receive 90% rMT iTBS over left DLPFC in this arm. The prefrontal hemodynamic response will be observed simultaneously before, during, and after iTBS using fNIRS.

    Device: Intermittent theta-burst stimulation (iTBS)

Interventions

  • DeviceIntermittent theta-burst stimulation (iTBS)

    The iTBS will be applied over lDLPFC with three different intensities. The investigators put the NIRS probe under the TMS coil to detect the hemodynamic signal simultaneously, and the applied rMT was adjusted based on Stokes et al., 2007. The equation is AdjMT% = MT + 2.8 \* (Dsitex - Dm1), and the thickness of the probe is 6mm, therefore, 2.8\*6=16.8(%) were added to the normal intensity.

    Also known as: Transcranial magnetic stimulation (TMS)

06

What researchers measure

Primary outcomes

  1. Oxygenated hemoglobin (HbO) change compared to baseline

    iTBS-induced HbO change in the DLPFC before, during and after stimulation

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

Secondary outcomes

  1. Deoxygenated hemoglobin (HbR) Change compared to baseline

    iTBS-induced HbR change in the DLPFC before, during and after stimulation

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

  2. Oxygen saturation change compared to baseline

    iTBS-induced oxygen saturation change in the DLPFC before, during and after stimulation

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

07

Study locations

1 site
  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05427552
Lead sponsor
The Hong Kong Polytechnic University
Responsible party
Dr Georg Kranz (Principal Investigator, The Hong Kong Polytechnic University) — Principal investigator
First posted
Jun 22, 2022
Start date
Jun 1, 2022
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Sep 15, 2022

Study contacts

Georg S Kranz, PhD
principal investigator · The Hong Kong Polytechnic University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion