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Completed

NCT Number: NCT05427552

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

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

About this study

Please refer to the full proposal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent theta-burst stimulation (iTBS)

Device

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.

Other names: Transcranial magnetic stimulation (TMS)

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2022
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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