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

Overview

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 us 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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 31, 2022

Detailed Description

Please refer to the full proposal

Interventions

  • Device: Intermittent theta-burst stimulation (iTBS)
    • The iTBS will be applied over lDLPFC with three different intensities. We 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, we add 2.8*6=16.8(%) to the normal intensity.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Right-handed 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Hong Kong Polytechnic University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Georg Kranz, Principal Investigator – The Hong Kong Polytechnic University
  • Overall Official(s)
    • Georg S Kranz, PhD, Principal Investigator, The Hong Kong Polytechnic University
  • Overall Contact(s)
    • Georg S Kranz, PhD, 2766, georg.kranz@polyu.edu.hk

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