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NCT06953362 · ClinicalTrials.gov registry record
Deciphering Principles of Network Dynamics Underlying Depression Symptom Severity From Multi-day Intracranial Recordings in Patients With Major Depression
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 6
- Enrollment target
NCT06953362: Completed study, sponsored by University of California, San Francisco.
NCT06953362 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06953362 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 6 participants
- Enrollment target
Study Summary
Major depressive disorder (MDD) is common and causes significant disability world-wide. While typically responsive to medications and therapy, there remain a subset of patients who are treatment resistant. Novel approaches are critical to treat these patients. MDD is likely caused by dysfunction in distributed neural networks, a perspective consistent with the etiological and diagnostic heterogeneity of this disorder. While imaging and electroencephalography (EEG) have helped identify MDD circuitry, no consensus has been reached on the identification of diagnostic biomarkers. Furthermore, the dynamics of MDD circuitry in relation to symptom severity is unknown. Characterization of circuit signatures that define MDD symptom severity states and the extent to which these circuits are modifiable using electrical stimulation are critical for therapeutic advancement. Intracranial EEG (iEEG) offers a high spatial and temporal resolution method to study depression networks. For the first time, we have an unparalleled opportunity to study such circuits in MDD patients participating in a clinical trial of personalized responsive neurostimulation for treatment resistant depression (PRESIDIO). In stage 1 of this trial, participants are implanted with 160 electrodes from 10 sub-chronic intracranial leads across 10 brain sites for 10 days. The goal of this parent study stage is to optimize brain-site targeting for deep brain stimulation. In the current project, we will leverage the opportunity to study MDD circuit principles from cortical and deep brain structures over a multi-day time period. In this ancillary study to the parent clinical trial, we carry out a set of experiments that establish basic principles of network dynamics underlying MDD from direct neural recordings. This study is organized around the principal concept that brain circuit dysfunction is reflected in abnormal signatures of functional connectivity and rhythmic local-field activity. This concept is supported
Primary Outcome
The pattern of network connectivity and activity that is associated with symptom severity and the effect of intracranial electrical stimulation on the connectivity and activity pattern.
Interventions
- DEVICE Direct Neural Electrical Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2024-12-31 |
What the finished NCT06953362 record still lists
NCT06953362 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Direct Neural Electrical Stimulation is the first listed.
NCT06953362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06953362 about?
NCT06953362 is a clinical study titled "Deciphering Principles of Network Dynamics Underlying Depression Symptom Severity From Multi-day Intracranial Recordings in Patients With Major Depression". Major depressive disorder (MDD) is common and causes significant disability world-wide. While typically responsive to medications and therapy, there remain a subset of patients who are treatment resistant. Novel approaches are critical to treat these patients. MDD is likely caused by dysfunction in ...
What is the current status of trial NCT06953362?
This trial is currently completed. The enrollment target is 6 participants. The study started on 2021-01-01. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT06953362?
The interventions under investigation include: Direct Neural Electrical Stimulation (DEVICE).
Who is sponsoring clinical trial NCT06953362?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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