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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427552
• Other study ID #: HSEARS20200120005-01
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please refer to the full proposal

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Deoxygenated hemoglobin (HbR) Change compared to baseline	iTBS-induced HbR change in the DLPFC before, during and after stimulation	During and post TBS-fNIRS measurement, up to 3 months
Secondary	Oxygen saturation change compared to baseline	iTBS-induced oxygen saturation change in the DLPFC before, during and after stimulation	During and post TBS-fNIRS measurement, up to 3 months