Identifying Local Field Potential Biomarkers for Obsessive-compulsive Disorder Treatment With Deep Brain Stimulation

Last updated: August 3, 2024
Sponsor: West China Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Panic Disorders

Kleptomania

Obsessive-compulsive Disorder

Treatment

Deep Brain stimulation

Clinical Study ID

NCT06542224
DBS-OCD-01
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 reuptakeinhibitors (including clomipramine) and augmentation agents, with no improvementafter continuous high-dose serotonin reuptake inhibitor treatment for more than 12weeks, 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 attendschool, or a noticeable decline in personal life skills.

  8. No severe impairment in insight, and capable of signing informed consent and surgeryconsent forms.

Exclusion

Exclusion Criteria:

  1. Presence of bipolar disorder, schizoaffective disorder, schizophrenia, or otherpsychotic 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 criteriawithin one year prior to screening.

  5. Study participants with contraindications for surgery, such as major medicalcomorbidities or inability to discontinue anticoagulant medications.

  6. Preoperative head MRI showing significant structural abnormalities.

  7. Contraindications for MRI examination (excluding the DBS implant or stimulatoritself).

  8. Pregnancy or breastfeeding.

  9. Study participants currently enrolled in another research study unrelated to thecurrent study.

  10. Any condition that currently or in the future might endanger the safety of the studyparticipant or prevent the successful participation in the study (including familysupport, medical, psychological, social, or geographical factors).

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Deep Brain stimulation
Phase:
Study Start date:
August 03, 2024
Estimated Completion Date:
December 03, 2026

Connect with a study center

  • The First People's hospital of Longquanyi District

    Chengdu, Sichuan
    China

    Site Not Available

  • West CHina Hospital,Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Zigong Fifth People's Hospital

    Zigong, Sichuan
    China

    Active - Recruiting

  • Zigong Fourth People's Hospital

    Zigong, Sichuan
    China

    Site Not Available

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