Obsessive-Compulsive DisorderDBS OCDNCT06542224
Identifying Local Field Potential Biomarkers for Obsessive-compulsive Disorder Treatment With Deep Brain Stimulation
A study testing Deep Brain stimulation in people with Obsessive-Compulsive Disorder, run by West China Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Deep Brain stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesChina
- Study dates
- 3 Aug 2024to 3 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
wei wang contact
China4 sites, 4 recruiting
- Recruiting
West CHina Hospital，Sichuan University
Chengdu, Sichuan, 610041
Botao Xiong, M.D., 13927498309, Botao-x@foxmail.com
Wei Wang
- Not yet recruiting
The First People's hospital of Longquanyi District
Chengdu, Sichuan
Mengfei Zeng, M.S.
- Recruiting
Zigong Fifth People's Hospital
Zigong, Sichuan
Ruifang cai, M.D., 13890018868
- Not yet recruiting
Zigong Fourth People's Hospital
Zigong, Sichuan
Chenghao Yang, M.D.
About this study
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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Deep Brain stimulation
- Keywords
- OCD, DBS, LFP, Biomarker
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain stimulationProcedure or surgery
All subjects will receive bilateral surgical implantation of DBS system.
| Study group | Role | What they receive |
|---|---|---|
| deep brain stimulation | Experimental | Not described Receives: Procedure: Deep Brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying an electrophysiological biomarker of OCD
Percentage of patients in which an electrophysiological biomarker of OCD can be identified before initial DBS
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start3 Aug 2024
- Primary completion3 Jul 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Pins Medical Co., Ltd
- Responsible party
- Principal investigator, Botao Xiong, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542224
- Sponsor's protocol ID
- DBS-OCD-01
- Acronym
- DBS OCD
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Local Field Potential Biomarkers for Obsessive-compulsive Disorder Treatment With Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT06542224
- Acronym / sponsor ID
- DBS OCD / DBS-OCD-01
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, DBS, LFP, Biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Beijing Pins Medical Co., Ltd
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 3 Jul 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deep brain stimulation | Experimental | Procedure: Deep Brain stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain stimulationAll subjects will receive bilateral surgical implantation of DBS system. | Procedure or surgery | deep brain stimulation |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
wei wang contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain stimulation in people with Obsessive-Compulsive Disorder, run by West China Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Botao Xiong, M.D. (13927498309, botao-x@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying an electrophysiological biomarker of OCD (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.