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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
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The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beam F3 targeting of accelerated iTBS | Active Comparator | Patients will receive anatomically-guided (Beam F3) accelerated iTBS. Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 10 treatment sessions daily for 5 consecutive workdays for a total of 50 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines. |
|
| Individualized connectome-guided accelerated iTBS | Experimental | Patients will receive individualized connectome-guided accelerated iTBS. Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 10 treatment sessions daily for 5 consecutive workdays for a total of 50 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beam F3 targeted accelerated iTBS | Device | Magpro X100, Axilium Cobot, Localite camera |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Ã…sberg Depression Rating Scale | Clinician rated depression rating scale, Scored 0 to 60, higher scores mean worse outcome | Baseline, immediately post treatment, 1 month and 3 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) | Participant rated depression rating scale, scored 0-27, higher scores mean worse outcome | Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention |
| Montreal Cognitive Assessment (MoCA) |
| Measure | Description | Time Frame |
|---|---|---|
| TMS induced changes in resting-fMRI functional connectivity | The investigators will also perform additional exploratory posthoc analyses by analysing brain imaging changes before and after TMS | Baseline, immediately post treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phern Chern Tor, MBBS | Contact | 63892000 | phern_chern_tor@imh.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Mental Health | Recruiting | Singapore | 539747 | Singapore |
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| Individualized connectome-guided accelerated iTBS | Device | Magpro X100, Axilium Cobot, Localite camera |
|
global cognitive functioning, scored 0-30, higher score means better outcome |
| Baseline, immediately post treatment, 1 month and 3 months post intervention |
| EQ-5D (EuroQol) | Quality of life scales, scored 0-100, higher scores mean better outcome | 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 14-70, higher score means better outcome | Baseline, immediately post treatment, 1 month and 3 months post intervention |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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