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

NCT ID: NCT06971549

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2025-06-30

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Accelerating TMS teatment

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.

Group Type: EXPERIMENTAL

Accelerated iTBS

Intervention Type: 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.

Interventions

Accelerated 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.

Intervention Type: OTHER

Eligibility Criteria

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;
• antiepileptics and benzodiazepines corresponding to a dose of >1 mg lorazepam/d.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Georg Kranz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georg Kranz, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Georg Kranz, PhD

Role: CONTACT

georg.kranz@polyu.edu.hk

27664838

Facility Contacts

Georg Kranz, PhD

Role: primary

georg.kranz@polyu.edu.hk

2766 ext. 4838

Other Identifiers

HSEARS20230705001-01

Identifier Type: -

Identifier Source: org_study_id