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Clinical Trials/NCT05427552
NCT05427552
Completed
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country24 target enrollmentJune 1, 2022
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
The Hong Kong Polytechnic University
Enrollment
24
Locations
1
Primary Endpoint
Oxygenated hemoglobin (HbO) change compared to baseline
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
August 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Georg Kranz

Principal Investigator

The Hong Kong Polytechnic University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Oxygen saturation change compared to baseline(During and post TBS-fNIRS measurement, up to 3 months)
  • Deoxygenated hemoglobin (HbR) Change compared to baseline(During and post TBS-fNIRS measurement, up to 3 months)

Study Sites (1)

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