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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Depression

Treatments: Other: Accelerated iTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06971549

HSEARS20230705001-01

Details and patient eligibility

About

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.

Enrollment: 1 estimated patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Accelerating TMS teatment

Experimental group

Description:

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.

Treatment:

Other: Accelerated iTBS