Accelerated iTBS for Depression: Monitoring Brain Hemodynamics With Simultaneous iTBS/fNIRS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Accelerated iTBS.
- Who it may be relevant to
- Registry conditions: Depression. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baseline [Time frame: Before, during and immediately after the intervention]
- Hamilton Depression Rating Scale (HAM-D) [Time frame: through study completion, an average of 5 days]
Secondary outcome measures (3)
- Montgomery-Asberg depression rating scale (MADRS) [Time frame: through study completion, an average of 5 days]
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: daily for 5 days]
- Verbal Analogue Scale (VAS) fatigue and pain level [Time frame: immediately after the intervention]
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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT06971549 · HSEARS20230705001-01