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

Not Applicable

Recruiting

• Conditions: Depression

• Registration Number: NCT06971549
• Lead Sponsor: The Hong Kong Polytechnic University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-19
• Study First Submitted: 2025-04-27
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baseline	Before, during and immediately after the intervention	iTBS-induced HbO and HbR change in the DLPFC before, during and after stimulation
Hamilton Depression Rating Scale (HAM-D)	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 Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	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.
Montgomery-Asberg depression rating scale (MADRS)	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.
Verbal Analogue Scale (VAS) fatigue and pain level	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).

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong