Clinical trial NCT06542224: Identifying Local Field Potential Biomarkers for Obsessive-compulsive Disorder Treatment With Deep Brain Stimulation
Official title: Identifying Local Field Potential Biomarkers for Obsessive-compulsive Disorder Treatment With Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
DBS
LFP
Biomarker
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Pins Medical Co., Ltd
First posted: 2024-08-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Identifying an electrophysiological biomarker of OCD
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West CHina Hospital，Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: The First People's hospital of Longquanyi District
state: Sichuan
city: Zigong
country: China
facility: Zigong Fifth People's Hospital
state: Sichuan
city: Zigong
country: China
facility: Zigong Fourth People's Hospital
state: Sichuan
Study officials:
References: