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

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ClinicalTrials.gov Identifier: NCT03667872
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depressive Disorder Procedure: Bilateral implantation of DBS system to Habeluna Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation in Patients With Treatment-Resistant Depression
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 18, 2020
Estimated Study Completion Date : June 18, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667872


Contacts
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Contact: Zhiyan Wang 010-60736388 wzyann@126.com

Locations
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China, Shenzhen
Habenula DBS Recruiting
Shenzhen, Shenzhen, China
Contact: Xiaodong Cai    0755-83366388      
Contact: Yingli Zhang    0755-25533524      
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd

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Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT03667872     History of Changes
Other Study ID Numbers: PINS-029
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beijing Pins Medical Co., Ltd:
Deep Brain Stimulation
Habenula
Functional magnetic resonance imaging

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders