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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05427552
Enrollment
24
Registered
2022-06-22
Start date
2022-06-01
Completion date
2022-08-31
Last updated
2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Theta-Burst stimulation (iTBS), Functional near-infrared spectroscopy (fNIRS), Concurrent TMS/fNIRS, Prefrontal hemodynamic response

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

Interventions

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Participants will not be informed of the stimulation intensities.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Oxygenated hemoglobin (HbO) change compared to baselineDuring and post TBS-fNIRS measurement, up to 3 monthsiTBS-induced HbO change in the DLPFC before, during and after stimulation

Secondary

MeasureTime frameDescription
Deoxygenated hemoglobin (HbR) Change compared to baselineDuring and post TBS-fNIRS measurement, up to 3 monthsiTBS-induced HbR change in the DLPFC before, during and after stimulation
Oxygen saturation change compared to baselineDuring and post TBS-fNIRS measurement, up to 3 monthsiTBS-induced oxygen saturation change in the DLPFC before, during and after stimulation

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026