Accelerated iTBS for Depression: Monitoring Brain Hemodynamics With Simultaneous iTBS/fNIRS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
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.
Intervention: Accelerated iTBS (Other)
Outcomes
Primary Outcomes
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
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
- Montgomery-Asberg depression rating scale (MADRS)(through study completion, an average of 5 days)
- Patient Health Questionnaire-9 (PHQ-9)(daily for 5 days)
- Verbal Analogue Scale (VAS) fatigue and pain level(immediately after the intervention)
Investigators
Dr Georg Kranz
Professor
The Hong Kong Polytechnic University