Efficacy and Safety of DBS in Patients With Treatment-Resistant Depression

December 24, 2018 updated by: Beijing Pins Medical Co., Ltd

Efficacy and Safety of MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation in Patients With Treatment-Resistant Depression

The habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicated that the lateral habeluna (LHb) is overactivity during depressive behaviors in rats, where it could drive the changes in midbrain monoamine neurotransmitter linked to depression. However, the efficiency and mechanism of deep brain stimulation (DBS) of the LHb and/or its major afferent bundle (i.e., stria medullaris thalami) could treat treatment-resistant major depression (TRD) is still unclear. This research will investigate the effectiveness and mechanism of bilateral MRI Compatible and Long-term LFP Recordable DBS to habenula and/or its major afferent bundle for treatment TRD patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

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

Study Locations

  • China
    • Shenzhen
      • Shenzhen, Shenzhen, China
        • Habenula DBS
        • Contact:
          • Xiaodong Cai
          • Phone Number: 0755-83366388
        • Contact:
          • Yingli Zhang
          • Phone Number: 0755-25533524

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-70 years old;
  • DSM-IV diagnosis of Major depression disorder of psychiatrists;
  • More than 3 year's history of depression and failure to respond to a minimum of three different antidepressant treatments;
  • Failure or intolerance or unwilling of an adequate course of electroconvulsive therapy (ECT) during any episode;
  • HAMD-17≥20;
  • GAF≤50；
  • Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria:

  • Obvious medical and psychiatric comorbidities;
  • Alcohol or substance abuse/dependence within 12 months;
  • Antisocial personality disorder, dementia, current tic disorder;
  • Subject has a history of 2 or more suicide attempts < 12 months prior to the screening testing;
  • Pregnancy and/or lactation;
  • There are contraindications for DBS surgery and chronic stimulation.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device
MRI compatible and LFP recordable implantable stimulator
Procedure: Bilateral implantation of DBS system to Habeluna
Bilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Hamilton Anxiety Scale
Time Frame: Baseline（preoperative）,3 months, 6 months, 12months
Change in the Hamilton Anxiety Scale after the DBS on
Baseline（preoperative）,3 months, 6 months, 12months

Collaborators and Investigators

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

Sponsor

Beijing Pins Medical Co., Ltd

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 (Anticipated)

January 15, 2019

Primary Completion (Anticipated)

June 18, 2020

Study Completion (Anticipated)

June 18, 2022

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 24, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Treatment Resistant Depressive Disorder

Clinical Trials on Bilateral implantation of DBS system to Habeluna

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe