Identifying brain biomarkers for treating obsessive-compulsive disorder with deep brain stimulation

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

This study is testing if deep brain stimulation can help people with obsessive-compulsive disorder who haven't found relief from regular treatments by looking for brain signals that might predict their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Locations: 4 sites (Chengdu, Sichuan and 3 other locations)
• Trial ID: NCT06542224 on ClinicalTrials.gov

What this trial studies

This study aims to identify brain-based biomarkers for obsessive-compulsive disorder (OCD) by utilizing deep brain stimulation (DBS) in patients who have not responded to standard treatments. The research involves long-term invasive neural signal collection from 16 OCD patients, combined with advanced machine learning techniques to analyze the relationship between these neural signals and OCD symptoms. The goal is to develop personalized models that can accurately predict the occurrence and progression of OCD based on individual differences in neural activity.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 diagnosed with OCD who have not benefited from standard pharmacological or psychological treatments.

Not a fit: Patients with severe personality disorders or other psychotic disorders such as bipolar disorder or schizophrenia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with OCD who currently do not respond to conventional therapies.

How similar studies have performed: While there is ongoing research in the field of deep brain stimulation for OCD, this specific approach of using machine learning to identify biomarkers is relatively novel and has not been extensively tested.

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).

Where this trial is running

Chengdu, Sichuan and 3 other locations

• West CHina Hospital，Sichuan University — Chengdu, Sichuan, China (Recruiting)
• The First People's hospital of Longquanyi District — Chengdu, Sichuan, China (Not_yet_recruiting)
• Zigong Fifth People's Hospital — Zigong, Sichuan, China (Recruiting)
• Zigong Fourth People's Hospital — Zigong, Sichuan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Botao Xiong, M.D.

Conditions Obsessive-Compulsive Disorder; OCD; DBS; LFP; Biomarker