CClinicalTrials.gg
CompletedNCT06971549Updated Sep 17, 2026

Accelerated iTBS for Depression: Monitoring Brain Hemodynamics With Simultaneous iTBS/fNIRS

An interventional study of Accelerated iTBS in Depression, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study will investigate the cortical hemodynamic response variability of an accelerated form of TBS stimulation over left dorsolateral prefrontal cortex (DLPFC) using a concurrent TBS/fNIRS setup. The accelerating TMS protocol that will be used in this study is similar to the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), i.e., fifty iTBS sessions (1,800 pulses per session, 50-minute intersession interval) will be delivered as 10 daily sessions over 5 consecutive days at 90% resting motor threshold. The investigators will recruit a depressed patient and conduct a concurrent iTBS/fNIRS protocol for each iTBS session. Moreover, the depression symptoms of the patient will be assessed before and after treatment.

02

Conditions studied

  • Depression

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Keywords

  • Theta-Burst stimulation (iTBS)
  • Functional near-infrared spectroscopy (fNIRS)
  • Concurrent TMS/fNIRS
  • Prefrontal hemodynamic response
03

In context

Depression

8,059 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 1 is below the median of 84 across 6,722 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • aged 18 to 65;
  • a clinical diagnosis of current nonpsychotic major depressive disorder by an experienced psychiatrist according to DSM-IV;
  • no or stable (≥2 weeks) psychopharmacological medication;
  • have not responded to at least one antidepressant medication;
  • have not received any TMS treatment;
  • and have a 17-item HAMD score ≥ 20.

Exclusion criteria

Exclusion Criteria:

  • severe internal diseases;
  • neurological disorders or a history of severe head injuries;
  • having suicidal ideation;
  • pregnancy;
  • common MRI, fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures
  • antiepileptics and benzodiazepines corresponding to a dose of >1 mg lorazepam/d.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Accelerating TMS treatment

    One depressed patient will be included in this study, which lasts for 5 consecutive days. During these 5 days, the participant will receive accelerated TMS treatment based on SAINT protocol, simultaneously monitored by concurrent TMS/fNIRS.

    Other: Accelerated iTBS

Interventions

  • OtherAccelerated iTBS

    Fifty iTBS sessions (1,800 pulses per session, 50-minute intersession interval) will be delivered as 10 daily sessions over 5 consecutive days at 90% resting motor threshold.

06

What researchers measure

Primary outcomes

  1. Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baseline

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

    Time frame: Before, during and immediately after the intervention

  2. Hamilton Depression Rating Scale (HAM-D)

    The Hamilton Depression Rating Scale, 17 item (HAM-D-17) is a simple, clinician-administered tool used to assess symptoms of depression experienced by a patient in the past week. The values of HAM-D-17 range from 0 to 52, and higher socres mean more severe symptoms.

    Time frame: through study completion, an average of 5 days

Secondary outcomes

  1. Montgomery-Asberg depression rating scale (MADRS)

    The Montgomery-Åsberg Depression Rating Scale is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.

    Time frame: through study completion, an average of 5 days

  2. Patient Health Questionnaire-9 (PHQ-9)

    Patient Health Questionnaire-9 (PHQ-9) is a 9-question instrument to screen for depression. Each item yields a score of 0 to 3; the overall score thus ranges from 0 to 27. Higher PHQ-9 score indicates more severe depression.

    Time frame: daily for 5 days

  3. Verbal Analogue Scale (VAS) fatigue and pain level

    The fatigue feelings of the patient will be assessed after each treatment, rated on a verbal analogue scale (VAS) ranging from 0 (no fatigue) to 10 (intolerable fatigue).

    Time frame: immediately after the intervention

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Study locations

1 site
  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06971549
Lead sponsor
The Hong Kong Polytechnic University
Responsible party
Dr Georg Kranz (Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
May 14, 2025
Start date
Mar 19, 2025
Primary completion
May 31, 2025
Completion
Jun 30, 2025
Last update
Sep 17, 2026

Study contacts

Georg Kranz, PhD
principal investigator · The Hong Kong Polytechnic University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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