Identifying Local Field Potential Biomarkers for Obsessive-compulsive Disorder Treatment With Deep Brain Stimulation (DBS OCD)

August 3, 2024 updated by: Botao Xiong, West China Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital,Sichuan University
        • Sub-Investigator:
          • Wei Wang
        • Contact:
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • The First People's hospital of Longquanyi District
        • Contact:
          • Mengfei Zeng, M.S.
      • Zigong, Sichuan, China
        • Recruiting
        • Zigong Fifth People's Hospital
        • Contact:
          • Ruifang cai, M.D.
          • Phone Number: 13890018868
      • Zigong, Sichuan, China
        • Not yet recruiting
        • Zigong Fourth People's hospital
        • Contact:
          • Chenghao Yang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with OCD according to the criteria in the DSM-5.
  2. Age between 18 and 65 years.
  3. Duration of illness of more than 3 years.
  4. 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.
  5. Ineffectiveness of CBT treatment or repeated refusal of CBT treatment.
  6. Y-BOCS total score of 25 or higher.
  7. Significant impairment in social functioning, such as inability to work or attend school, or a noticeable decline in personal life skills.
  8. No severe impairment in insight, and capable of signing informed consent and surgery consent forms.

Exclusion Criteria:

  1. Presence of bipolar disorder, schizoaffective disorder, schizophrenia, or other psychotic disorders.
  2. Severe personality disorders.
  3. Severe physical illnesses or organic brain diseases.
  4. Diagnosis of alcohol or substance abuse and dependence according to DSM-IV criteria within one year prior to screening.
  5. Study participants with contraindications for surgery, such as major medical comorbidities or inability to discontinue anticoagulant medications.
  6. Preoperative head MRI showing significant structural abnormalities.
  7. Contraindications for MRI examination (excluding the DBS implant or stimulator itself).
  8. Pregnancy or breastfeeding.
  9. Study participants currently enrolled in another research study unrelated to the current study.
  10. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: deep brain stimulation
Procedure: Deep Brain stimulation
All subjects will receive bilateral surgical implantation of DBS system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identifying an electrophysiological biomarker of OCD
Time Frame: 30 days
Percentage of patients in which an electrophysiological biomarker of OCD can be identified before initial DBS
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Collaborators

Beijing Pins Medical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2024

Primary Completion (Estimated)

July 3, 2026

Study Completion (Estimated)

December 3, 2026

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBS-OCD-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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