The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Obsessive-Compulsive Disorder

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02253472

Enrollment

Registered

2014-10-01

Start date

2016-12-31

Completion date

2018-12-31

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder

Brief summary

The purpose of this clinical study is To verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Obsessive-Compulsive Disorder.

Interventions

DEVICEDeep Brain Stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Obsessive compulsive disorder (according to DSM IV-criteria) as the primary psychiatric diagnosis. 2. Severity level of OCD more than 25 on the Yale-Brown Obsessive Compulsive Scale. 3. Course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance). 4. Treatment resistance: at least two serotonin reuptake inhibitors (SSRI´s), or one SSRI and clomipramine in 5.Sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic Lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including exposure and response Prevention of a minimum of 20 sessions with a documented lack of efficiency. 6.The ability to give written and informed consent.

Exclusion criteria

1. Co-morbid psychotic disorder according to DSM-IV criteria 2. Suicidal tendencies in the last 6 months 3. History of cerebral trauma 4. Clinically relevant internal or neurological disorder 5. Substance misuse or dependence in the last six months 6. Ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a DBS 7. Participate in other clinical trial 8. The investigator and/or enrollment review committee, would preclude participation in the study

Design outcomes

Primary

Measure	Time frame
Yale-Brown obsessive-compulsive psychiatrists rating scale(Y-BOCS)	12 month

Secondary

Measure	Time frame
Hamilton anxiety scale (HAMD)	12 month

Contacts

Primary ContactJia Fumin, PhD

pins_medical@163.com010-59361265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026