The Efficacy and Mechanism of DBS in VIC and NAcc for Refractory OCD
NCT ID: NCT04228744
Last Updated: 2020-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2020-01-10
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bilateral surgical implantation of DBS system
All the participants will receive bilateral surgical implantation of DBS system to VIC and NAc. The experimenter will active the DBS system and adjust the parameters for all the participants after surgery.
DBS system
The DBS device utilized in the present study includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller. The lead contains four stimulating contacts. The length of each contact is 1.5 mm, and the spacing between contacts is 1.5 mm.
The participants will receive stepwise surgery. The electrodes will be implanted firstly which will be externalized for several days and then the IPG will be implanted. During externalization, the experimenters will record the local field potential and electroencephalography in resting or task-based state with conditions of sham-stimulation or active-stimulation.
Interventions
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DBS system
The DBS device utilized in the present study includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller. The lead contains four stimulating contacts. The length of each contact is 1.5 mm, and the spacing between contacts is 1.5 mm.
The participants will receive stepwise surgery. The electrodes will be implanted firstly which will be externalized for several days and then the IPG will be implanted. During externalization, the experimenters will record the local field potential and electroencephalography in resting or task-based state with conditions of sham-stimulation or active-stimulation.
Eligibility Criteria
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Inclusion Criteria
2. Severity rated as severe to extreme illness;
3. Failed adequate trial of at least three specific serotonin reuptake inhibitor (SSRI) antidepressants;
4. Failed augmentation with antipsychotic;
5. Completed or failed to complete adequate trial of cognitive behavioural therapy for OCD;
6. Stable medication regimen for one month before surgery;
7. Signed informed consent;
Exclusion Criteria
2. No other serious psychiatric disorder such as psychotic disorder;
3. Drug or substance use disorder within 6 months except nicotine;
4. Major Neurological/Medical condition;
5. High suicide risk;
6. Pregnancy or lactation;
7. Contraindications to stereotactic surgery;
8. Contraindications to MRI;
18 Years
65 Years
ALL
No
Sponsors
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University of Cambridge
OTHER
Ruijin Hospital
OTHER
Responsible Party
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Bomin Sun
Director of Functional Neurosurgery Department
Principal Investigators
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Bomin Sun, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Valerie Voon, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Locations
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Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019 NAc VIC DBS OCD
Identifier Type: -
Identifier Source: org_study_id
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