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

October 13, 2016 updated by: Beijing Pins Medical Co., Ltd
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deep Brain Stimulation
Stimulation is on.
Device: Deep Brain Stimulation
Other Names:
  • Implanted device
Sham Comparator: Placebo
Stimulation is off.
Device: Deep Brain Stimulation
Other Names:
  • Implanted device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Hamilton anxiety scale (HAMD)
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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