Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment

NCT07779330 | Not Yet Recruiting

• 1 other identifier: 2026-0652
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Depression; iTBS; Neuronavigated; Maintenance; Relapse; Treatment resistant depression

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in response

  The investigators will compute the percentage of time spent in TRD response over the course of each participant's time in the study. TRD response is defined by fulfilling the low relapse criteria in accordance with the STABLE algorithm. In this study, low relapse potential would be a MADRS score of ≤9 or a MADRS score of 10-19 with \<3-point increase from baseline, and \<5-point increase in 4 consecutive weeks at any point in the study.

  Baseline, and weekly for 12 months.

Secondary Outcomes (7)

• Quick Inventory of Depressive Symptomatology (16-item) Self-Report (QIDS-SR16)

  Baseline, and weekly for 12 months.

• Beck Anxiety Index (BAI)

  Baseline, and weekly for 12 months.

• General Anxiety Disorder-7 (GAD-7)

  Baseline, and weekly for 12 months.

• EuroQol 5-Dimension (EQ-5D)

  Full questionnaire is administered at baseline, and weekly for 12 months. The VAS section of the questionnaire is logged daily for 12 months.

• Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)

  Baseline, and weekly for 12 months.

Study Arms (1)

Individualized, resting-state functional connectivity-guided accelerated iTBS

EXPERIMENTAL

Device: Individualized resting-state functional connectivity-guided iTBS; Diagnostic Test: Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm

Interventions

Individualized resting-state functional connectivity-guided iTBS DEVICE

MagPro X100, Axilium Cobot, Localite Camera

Individualized, resting-state functional connectivity-guided accelerated iTBS

Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm DIAGNOSTIC_TEST

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.

Individualized, resting-state functional connectivity-guided accelerated iTBS

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/ female aged ≥ 21 to ≤ 70 years old
• Able to give informed consent
• Able to understand English
• DSM-V diagnosis of current/ past major depressive disorder (MDD) episode
• Non-response to an adequate trial (4 weeks) of at least 1 MDD medication as verified by a study clinician
• Ability to comply with passive wearable use and weekly mobile assessments
• Have previously completed a course of individualized, functional connectivity-guided accelerated iTBS and shown a clinical response (as defined by a ≥50% improvement in MADRS score against baseline, any time within 3 months following an acute iTBS course)
• Able to comply with the full 12-month protocol inclusive of continuous digital monitoring

You may not qualify if:

• DSM-5 psychotic disorder
• Drug or alcohol abuse or dependence (preceding 3 months)
• Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
• Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pump or any other electronic implants or devices
• Tattoos containing ferromagnetic ink or permanent piercings
• Pregnancy
• Currently on multiple CNS stimulant medications (2 or more at maximal clinical doses)
• Participant does not have the capacity to provide consent

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital, Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Depression; Recurrence; Depressive Disorder, Treatment-Resistant

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Central Study Contacts

Phern Chern Tor, MBBS

CONTACT

+65 6908 2222; cip@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)