Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06542224

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First People's hospital of Longquanyi District, Chengdu, Sichuan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Deep Brain Stimulation

Procedure

All subjects will receive bilateral surgical implantation of DBS system.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Botao Xiong, M.D.

CONTACT

[email protected]

13927498309

wei wang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Collaborators

  • Beijing Pins Medical Co., Ltd

Registry information

Acronym: DBS OCD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.