MedDataX Logo

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

NCT ID: NCT03667872

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2022-06-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Treatment Resistant Depressive Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Deep Brain Stimulation Habenula Functional magnetic resonance imaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Device

MRI compatible and LFP recordable implantable stimulator

Group Type EXPERIMENTAL

Bilateral implantation of DBS system to Habeluna

Intervention Type PROCEDURE

Bilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bilateral implantation of DBS system to Habeluna

Bilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Habenula DBS

Shenzhen, Shenzhen, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhiyan Wang

Role: CONTACT

Phone: 010-60736388

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiaodong Cai

Role: primary

Yingli Zhang

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PINS-029

Identifier Type: -

Identifier Source: org_study_id