This proposal seeks to conduct a pragmatic single arm, open label pilot implementation to validate our individualized functional Magnetic Resonance Imaging (fMRI) connectome-guided localization approach for accelerated TMS among Asian patients with depression. Participants will be patients with Major Depressive Disorder not responding to standard treatment, with no exclusions to fMRI or transcranial magnetic stimulation (TMS) (essentially metal implants in the head) and willing to participate in the pilot. All participants will undergo MRI scans before and after the accelerated TMS treatment. The multi-session hierarchical Bayesian model (MS-HBM) approach will be used to estimate individualized connectome-guided target locations. Patients will undergo accelerated TMS applied to individualized connectome-guided target locations (based on the MS-HBM approach). Patients will undergo 10 sessions (each session lasting 10 min) spread out over 10 hours each day for 5 consecutive working days. All clinical outcome data will be collected for each patient by a pre-defined questionnaire at four time points: at baseline, post-treatment, 1 month and 3 months during follow-up. The clinical outcome data will be analyzed using linear regression or repeated analysis of variance (ANOVA) after adjusting for baseline clinical characteristics and socio-demographics. Trajectories of the clinical outcome data at baseline, post-treatment and all follow-up time points will be plotted and compared with time series statistical analysis models with the other clinical and socio-demographic characteristics included as confounders.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
MagproX 100 and Axilium Cobot with Localite camera
Institute of Mental Health
Singapore, Singapore
RECRUITINGMontgomery-Åsberg Depression Rating Scale (MADRS)
Clinician rated Depression rating scale, range of scores 0 to 60 with higher scores meaning a worse outcome
Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-16)
Patient rated Depression rating scale, scored 0-27 with higher scores meaning a worse outcome
Time frame: Baseline, (Days 1-5 of treatment), immediately after intervention, 1 month and 3 months post intervention
Montreal Cognitive Assessment (MoCA),
global cognitive functioning, scored 0 to 30 with higher scores meaning better outcome
Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
EuroQol- 5 Dimension (EQ-5D)
Quality of life scales, Visual analogue scale 0-100 with higher scores meaning better outcome
Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)
Quality of life scales, scored 0-70 with higher scores meaning better outcome
Time frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
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