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

NCT ID: NCT05427552

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Please refer to the full proposal

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will not be informed of the stimulation intensities.

Study Groups

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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.

Group Type EXPERIMENTAL

Intermittent theta-burst stimulation (iTBS)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Intermittent theta-burst stimulation (iTBS)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Intermittent theta-burst stimulation (iTBS)

Intervention Type 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.

Interventions

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Intermittent 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.

Intervention Type DEVICE

Other Intervention Names

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Transcranial magnetic stimulation (TMS)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Georg Kranz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg S Kranz, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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HSEARS20200120005-01

Identifier Type: -

Identifier Source: org_study_id

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