Identifying Local Field Potential Biomarkers for Obsessive-compulsive Disorder Treatment With Deep Brain Stimulation
DBS OCD
1 other identifier
interventional
16
1 country
4
Brief Summary
Obsessive-compulsive disorder (OCD) is a complex and severe mental illness characterized by multiple symptoms and is considered a leading cause of non-fatal health loss. However, nearly 20% of patients do not respond to standard pharmacological or psychological treatments. Currently, we lack objective brain-based biomarkers. To address this issue, we used a novel device for electrophysiology recording and applied deep brain stimulation (DBS) to 16 OCD patients. In this study, we aim to use long-term invasive neural signal collection and machine learning techniques to reveal the complex relationship between these signals and OCD 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 OCD. The research will focus on the spatiotemporal features of neural signals and build personalized OCD 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 provide academic and practical innovations for the development of personalized treatment approaches for OCD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2024
CompletedStudy Start
First participant enrolled
August 3, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 3, 2026
August 7, 2024
August 1, 2024
1.9 years
August 3, 2024
August 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identifying an electrophysiological biomarker of OCD
Percentage of patients in which an electrophysiological biomarker of OCD can be identified before initial DBS
30 days
Study Arms (1)
deep brain stimulation
EXPERIMENTALInterventions
All subjects will receive bilateral surgical implantation of DBS system.
Eligibility Criteria
You may qualify if:
- Diagnosed with OCD according to the criteria in the DSM-5.
- Age between 18 and 65 years.
- Duration of illness of more than 3 years.
- Ineffectiveness of systematic treatment with three types of serotonin reuptake inhibitors (including clomipramine) and augmentation agents, with no improvement after continuous high-dose serotonin reuptake inhibitor treatment for more than 12 weeks, or the occurrence of severe adverse drug reactions during treatment.
- Ineffectiveness of CBT treatment or repeated refusal of CBT treatment.
- Y-BOCS total score of 25 or higher.
- Significant impairment in social functioning, such as inability to work or attend school, or a noticeable decline in personal life skills.
- No severe impairment in insight, and capable of signing informed consent and surgery consent forms.
You may not qualify if:
- Presence of bipolar disorder, schizoaffective disorder, schizophrenia, or other psychotic disorders.
- Severe personality disorders.
- Severe physical illnesses or organic brain diseases.
- Diagnosis of alcohol or substance abuse and dependence according to DSM-IV criteria within one year prior to screening.
- Study participants with contraindications for surgery, such as major medical comorbidities or inability to discontinue anticoagulant medications.
- Preoperative head MRI showing significant structural abnormalities.
- Contraindications for MRI examination (excluding the DBS implant or stimulator itself).
- Pregnancy or breastfeeding.
- Study participants currently enrolled in another research study unrelated to the current study.
- Any condition that currently or in the future might endanger the safety of the study participant or prevent the successful participation in the study (including family support, medical, psychological, social, or geographical factors).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West China Hospitallead
- Beijing Pins Medical Co., Ltdcollaborator
Study Sites (4)
West CHina Hospital，Sichuan University
Chengdu, Sichuan, 610041, China
The First People's hospital of Longquanyi District
Chengdu, Sichuan, China
Zigong Fifth People's Hospital
Zigong, Sichuan, China
Zigong Fourth People's Hospital
Zigong, Sichuan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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