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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West CHina Hospital，Sichuan University
  Chengdu, Sichuan, China Recruiting
• Zigong Fifth People's Hospital
  Zigong, Sichuan, China Recruiting
• The First People's hospital of Longquanyi District
  Chengdu, Sichuan, China Not yet recruiting
• Zigong Fourth People's Hospital
  Zigong, Sichuan, China Not yet recruiting

Study contacts

• Study coordinator: Botao Xiong, M.D.
• Email: botao-x@foxmail.com
• Phone: 13927498309

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• AttunE LIFU for OCD: a non-invasive brain stimulation study

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• Combined ERP and Habit Reversal Therapy for Tourettic OCD

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.