Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment
NCT07779330 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-08-21
Summary
This proposal seeks to carry out a prospective, single-arm open label study aimed at sustaining treatment-resistant depression (TRD) response in patients with TRD who had responded to prior individualized resting-state functional connectivity (rs-FC)-guided intermittent theta burst stimulation (iTBS). It also seeks to detect and predict relapse risk by integrating rs-FC iTBS with a TMS-adapted needs-based symptom-titrated algorithm based longitudinal ECT (STABLE) maintenance scheduling algorithm, and passive digital biomarkers.
Conditions
- Depression Disorder
Interventions
- DEVICE
-
Individualized resting-state functional connectivity-guided iTBS
MagPro X100, Axilium Cobot, Localite Camera
- DIAGNOSTIC_TEST
-
Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm
The STABLE relapse detection algorithm provides a symptom-driven retreatment scheduling. It is validated to prolong TRD response to electroconvulsive therapy (ECT) while minimizing overtreatment. The algorithm will be adapted for TMS and will be used to determine the need for maintenance iTBS treatment.
Sponsors & Collaborators
-
National University of Singapore
collaborator OTHER -
National University Hospital, Singapore
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-09-30
- Completion
- 2029-12-31
Countries
- Singapore
Study Locations
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