Brain stimulation and wearable sensors to maintain response in resistant depression
Tests brain stimulation maintenance in adults with treatment-resistant depression who responded earlier.
Plain-language title generated from the registry record
Registry title: Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment
Key facts
- Where
- Singapore, SingaporeSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 70 years old?
Source: NCT07779330, who can take part
Where in Singapore
- National University Hospital SingaporeSingapore, SingaporeNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National University Hospital, Singapore
- Trial code
- NCT07779330
- Record updated
- 2 September 2026
- Original description
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.Read full original descriptionShow less
MINDSET: Maintenance Individualized Neuromodulation and Depression-detection Via Sensors for Early Treatment
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.
Inclusion: 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.
Exclusion: Drug or alcohol abuse or dependence (preceding 3 months); Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pump or any other electronic implants or devices; Currently on multiple CNS stimulant medications (2 or more at maximal clinical doses); DSM-5 psychotic disorder; Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy; Tattoos containing ferromagnetic ink or permanent piercings; Pregnancy; Participant does not have the capacity to provide consent.