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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05427552
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
3
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intermittent theta-burst stimulation (iTBS)
 N/A

Detailed Description

Please refer to the full proposal

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Masking Description:
Participants will not be informed of the stimulation intensities.
Primary Purpose:
Basic Science
Official Title:
Exploring the Cortical Hemodynamic Response of Excitatory Brain Stimulation: a Pilot Study
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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)
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)

    		•
    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)
    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)

    		•
    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)
    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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Oxygenated hemoglobin (HbO) change compared to baseline [During and post TBS-fNIRS measurement, up to 3 months]

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

    Secondary Outcome Measures

    1. Deoxygenated hemoglobin (HbR) Change compared to baseline [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 [During and post TBS-fNIRS measurement, up to 3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Hong Kong Polytechnic University Hong Kong Hong Kong

    Sponsors and Collaborators

    • The Hong Kong Polytechnic University

    Investigators

    • Principal Investigator: Georg S Kranz, PhD, The Hong Kong Polytechnic University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Georg Kranz, Principal Investigator, The Hong Kong Polytechnic University
    ClinicalTrials.gov Identifier:
    NCT05427552
    Other Study ID Numbers:
    • HSEARS20200120005-01
    First Posted:
    Jun 22, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Dr Georg Kranz, Principal Investigator, The Hong Kong Polytechnic University
    Theta-Burst stimulation (iTBS)
    Functional near-infrared spectroscopy (fNIRS)
    Concurrent TMS/fNIRS
    Prefrontal hemodynamic response

    Study Results

    No Results Posted as of Aug 4, 2022