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

NCT05427552 | Completed

• 1 other identifier: HSEARS20200120005-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

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

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 (3)

Prefrontal hemodynamic response to 50% rMT iTBS

EXPERIMENTAL

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)

Prefrontal hemodynamic response to 70% rMT iTBS

EXPERIMENTAL

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)

Prefrontal hemodynamic response to 90% rMT iTBS

EXPERIMENTAL

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

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.

Also known as: Transcranial magnetic stimulation (TMS)

Prefrontal hemodynamic response to 50% rMT iTBS; Prefrontal hemodynamic response to 70% rMT iTBS; Prefrontal hemodynamic response to 90% rMT iTBS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-handed

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Georg S Kranz, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed of the stimulation intensities.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Healthy volunteers will receive iTBS three times with three different intensities separated by one week to investigate the prefrontal hemodynamic response to different stimulation intensities.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: June 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)