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Treatment Resistant Depression / Medtronic Activa PC+S System · Interventional Study
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an ongoing, uncontrolled single-arm study of the Medtronic Activa PC+S neuromodulation device in 10 people with treatment-resistant depression. The study aims to characterize local field potential recordings and changes in Hamilton Depression Rating Scale scores during and after stimulation, with follow-up to 10 years. No results are posted in this registry entry.
Interventional, Single Group, Open label, Treatment purpose. Treatment Resistant Depression; age from 25 Years; to 70 Years. Intervention: DBS for Treatment Resistant Depression. n = 10. 1 site: United States.
This is a registry record for an ongoing, uncontrolled single-arm study of the Medtronic Activa PC+S neuromodulation device in 10 people with treatment-resistant depression. The study aims to characterize local field potential recordings and changes in Hamilton Depression Rating Scale scores during and after stimulation, with follow-up to 10 years. No results are posted in this registry entry.
This is a registry record; no efficacy or safety results are reported.
This mechanistic study is not yet positioned to inform clinical practice; publication of results characterizing neural biomarkers and depression symptom change will be needed to determine whether the Activa PC+S approach warrants advancement to controlled efficacy trials.
This is an active, uncontrolled single-arm device feasibility study with 10 enrolled participants designed to characterize neural mechanisms rather than establish efficacy; no results are reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This mechanistic study is not yet positioned to inform clinical practice; publication of results characterizing neural biomarkers and depression symptom change will be needed to determine whether the Activa PC+S approach warrants advancement to controlled efficacy trials.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT01984710). This is a study registration, not published results. Lead sponsor: Emory University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 10 participants (ACTUAL). Conditions: Treatment Resistant Depression. Interventions: DEVICE: Medtronic Activa PC+S System. Primary outcome measures: Changes in Activa PC+S Local Field Potential (LFP) Recordings , From Day 1, up to 3 years; Change in Hamilton Depression Rating Scale-17 Score , Baseline; Recovery period with stimulation off: 24 hours post-operative, Weeks 1, 2, 3, 4; Stimulation phase: every 1-2 weeks up to week 30; Naturalistic follow up: every 1 to 6 months for up to 10 years. Brief summary: The goal of this study is to use the Activa Primary Cell + Sensing (PC+S) device to study Latent Field Potential (LFP) in the brains of people with Treatment Resistant Depression (TRD) before and during active stimulation. The ultimate goal is to understand the neural network that causes TRD and the changes that DBS cause in that network that results in the antidepressant effects.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.