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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Intermittent theta-burst stimulation (iTBS)

• Registration Number: NCT05427552
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Please refer to the full proposal

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prefrontal hemodynamic response to 90% rMT iTBS	Intermittent theta-burst stimulation (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.
Prefrontal hemodynamic response to 50% rMT iTBS	Intermittent theta-burst stimulation (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.
Prefrontal hemodynamic response to 70% rMT iTBS	Intermittent theta-burst stimulation (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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong