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NCT Number: NCT06971549

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Location status: Recruiting

Location contact

Georg Kranz, PhD

CONTACT

[email protected]

2766 ext. 4838

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Accelerated iTBS

Other

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.

Primary outcomes

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

    Time frame: Before, during and immediately after the intervention

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

  2. Hamilton Depression Rating Scale (HAM-D)

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

    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.

Secondary outcomes

  1. Montgomery-Asberg depression rating scale (MADRS)

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

    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.

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

    Time frame: daily for 5 days

    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.

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

    Time frame: immediately after the intervention

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Georg Kranz, PhD

CONTACT

[email protected]

27664838

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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