Identifying Local Field Potential Biomarkers for Treatment-Resistant Major Depression With Deep Brain Stimulation

NCT06542094 | Recruiting DMC

• 1 other identifier: DBS-MDD-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder (MDD) is a complex and severe mental illness, characterized by multiple symptoms, and is a leading cause of non-fatal health loss. Despite this, approximately 30% of patients do not respond to standard pharmacological or psychological treatments. Currently, we lack objective brain-based biomarkers to differentiate between natural mood fluctuations and situations requiring intervention. To address this issue, we employed a novel electrophysiology recording device and applied deep brain stimulation (DBS) to 12 MDD patients. Our study aims to use long-term invasive neural signal collection and machine learning techniques to reveal the complex relationship between these signals and depressive symptoms. By applying advanced machine learning algorithms, our goal is to establish highly accurate prediction models to identify biomarkers associated with the occurrence and progression of depression. The research will focus on the spatiotemporal features of neural signals and build personalized depression decoding models based on individual differences through the integration and analysis of large-scale data. By delving into the information contained in neural signals, we hope to contribute to the development of personalized treatment approaches for depression.

Conditions

Major Depressive Disorder; Treatment Resistant Depression

Keywords

TRD，DBS，Biomarker，LFP

Outcome Measures

Primary Outcomes (1)

• Identifying an electrophysiological biomarker of MDD

  Percentage of patients in which an electrophysiological biomarker of OCD can be identified before initial DBS

  30 days

Study Arms (1)

deep brain stimulation

EXPERIMENTAL

Procedure: Deep Brain stimulation

Interventions

Deep Brain stimulation PROCEDURE

All subjects will receive bilateral surgical implantation of DBS system.

deep brain stimulation

Eligibility Criteria

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

You may qualify if:

• \) Participants in the study should sign a research informed consent form before starting any research-related procedures; 2) Participants must be between the ages of 16 and 30, regardless of gender; 3) Diagnosed with Major Depressive Disorder (MDD) according to the diagnostic criteria in the DSM-V; 4) Participants must have medical records of their current depressive episode that has lasted for ≥2 years, or recurrent episodes, with a minimum of 4 episodes (with the current episode lasting at least 1 year); 5) Have previously failed at least 3 courses of adequate antidepressant therapy, using 2 or more different classes of antidepressants; and have refused, been unable to tolerate, or found electroconvulsive therapy (ECT) to be ineffective; 6) Participants must have a HAMD-17 score of ≥20 or a MADRS score of ≥25; 7) Participants must be able to communicate effectively, and the participant and their legal guardian must sign a written informed consent form.

You may not qualify if:

• \) Participants with bipolar disorder, schizoaffective disorder, schizophrenia, or other psychotic disorders; 2) Severe personality disorders; 3) Severe physical diseases or organic brain diseases; 4) Participants with alcohol or substance abuse and dependence diagnosed within 1 year prior to screening according to DSM-IV criteria; 5) Participants with surgical contraindications, such as significant comorbid medical conditions or inability to discontinue anticoagulation medications; 6) Structural imaging abnormalities evident on MRI performed within 1 year prior to screening; 7) MRI contraindications (excluding DBS implantation or the device itself); 8) Pregnant or breastfeeding; 9) Participants who are enrolled in another study unrelated to the current study; 10) Any condition that may currently or potentially endanger the participant's safety or preclude their successful participation in the study (family support, medical, psychological, social, or geographic factors).

Sponsors & Collaborators

• West China Hospital: lead
• Beijing Pins Medical Co., Ltd: collaborator

Study Sites (1)

West CHina Hospital，Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

wei wang, M.D.

CONTACT

+86 13808170699; wcnsww@163.com

Botao Xiong, M.D.

CONTACT

+86 13927498309; Botao-x@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant research fellow

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: August 3, 2024
• Primary Completion (Estimated): July 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)