A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression
NCT ID: NCT06385223
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-07-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Beam F3 targeting of accelerated iTBS
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.
Beam F3 targeted accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera
Individualized connectome-guided accelerated iTBS
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.
Individualized connectome-guided accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera
Interventions
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Beam F3 targeted accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera
Individualized connectome-guided accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera
Eligibility Criteria
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Inclusion Criteria
2. DSM-5 diagnosis of current Major Depressive Episode.
3. Montgomery-Asberg Depression Rating Scale score of 20 or more.
4. Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
5. Able to give informed consent.
Exclusion Criteria
2. Drug or alcohol abuse or dependence (preceding 3 months).
3. Rapid clinical response required, e.g., high suicide risk.
4. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
5. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
6. Pregnancy.
7. Unsuitable for MRI.
21 Years
ALL
No
Sponsors
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National University of Singapore
OTHER
Institute of Mental Health, Singapore
OTHER
Responsible Party
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Locations
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Institute of Mental Health
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DSRB 2023/00680
Identifier Type: -
Identifier Source: org_study_id
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