Depression
Conditions
Keywords
Theta-Burst stimulation (iTBS), Functional near-infrared spectroscopy (fNIRS), Concurrent TMS/fNIRS, Prefrontal hemodynamic response
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.
Interventions
OTHERAccelerated 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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
Countries
Hong Kong
Contacts
Primary ContactGeorg Kranz, PhD
Outcome results
None listed