Efficacy of Deep Brain Stimulation(DBS) for Treatment-Resistant Depression(TRD)

NCT ID: NCT06542900

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-10
• Study Completion Date: 2029-12-31

Brief Summary

The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) implantation in patients with Treatment-resistant Depression (TRD) targeting the ventral capsule/ventral striatum (VC/VS), Brodmann area 25/subcallosal cingulate (SCC), Anterior Limb of Internal Capsule (ALIC), inferior thalamic peduncle (ITP), nucleus accumbens (NAc), lateral habenula (LHb), medial forebrain bundle (MFB), or other unreported nuclei targets.

Detailed Description

At least 40-60% of people with major depressive disorders (MDD) continue to have symptoms after treatment. The pharmacology treatment cannot produce sustained antidepressant effects in 50% of patients with depression. Therefore, more effective therapeutic methods are urgently needed. In a comprehensive survey of diverse neuromodulation therapies, targeting specific nuclei with deep brain stimulation (DBS) has the most potential for Treatment-resistant Depression (TRD) with apparent symptoms. The stimulation targets of DBS for patients with obsessive-compulsive disorder include the ventral capsule/ventral striatum (VC/VS), Brodmann area 25/subcallosal cingulate (SCC), Anterior Limb of Internal Capsule (ALIC), inferior thalamic peduncle (ITP), nucleus accumbens (NAc), lateral habenula (LHb), and medial forebrain bundle (MFB). However, the DBS case reports are limited and lack high-quality, evidence-based medical evidence. So, this cohort study focuses on the effectiveness of DBS-targeted VC/VS, SCC, ALIC, ITP, NAc, LHb, MFB, or other unreported nuclei targets on TRD.

Another goal of this program is to study the neuronal activity of the VC/VS, SCC, ALIC, ITP, NAc, LHb, MFB, or other unreported nuclei targets, respectively. At the same time, some subjects are presented with a task involving an unexpected reward. This separate study is an option and will not affect current study participation.

Some participants will also be invited to join a related study that involves positron emission tomography (PET) scanning to determine how the stimulation changes activity in the brain. Participation in the separate PET study is optional and will not affect current study participation.

Conditions

Treatment Resistant Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Treatment-Resistant Depression (TRD)

Patients will undergo bilateral DBS lead implantation.

Group Type: EXPERIMENTAL

Deep Brain Stimulation (DBS)

Intervention Type: DEVICE

The DBS lead is stereotactically introduced into the target in the brain (SCC, VC/VS, ALIC, ITP, NAc, LHb, MFB, or other unreported nuclei targets) and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Interventions

Deep Brain Stimulation (DBS)

The DBS lead is stereotactically introduced into the target in the brain (SCC, VC/VS, ALIC, ITP, NAc, LHb, MFB, or other unreported nuclei targets) and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. male or female, 18-65 years old;

2. able to provide written informed consent voluntarily;

3. had a diagnosis of major depression disorder (MDD) (recurrent episodes) without psychotic features in compliance with the Diagnostic and Statistical Manual of Mental Disorders -Fourth Edition -Text Revised (DSM-IV-TR) and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;

4. failure of response to at least two antidepressant medication trials based on the Massachusetts General Hospital antidepressant treatment response questionnaire (MGH-ATRQ);

5. ongoing antidepressant(s) at a fixed dose for at least four weeks before baseline assessment;

6. had a score of ≥201 on the Hamilton Depression Scale- item 17 (HAMD-17) at baseline.

Exclusion Criteria

1. presence of other psychotic disorders;

2. have a treatment history that includes electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), DBS, and transcranial magnetic stimulation (TMS);

3. presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);

4. experience difficulty in effectively communicating with investigators;

5. with a history of traumatic brain injury (TBI);

6. with intracranial or cardiovascular stents;

7. substance abuse within the past six months;

8. unstable neurological or coagulation disorders;

9. women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;

10. have been involved in other clinical studies within three months before enrollment in this study;

11. any conditions considered by the study group.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongxing Wang, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Countries

China

Central Contacts

Huang Wang, MD

Role: CONTACT

wanghuang118@mail.ccmu.edu.cn

+86 10 83198650

Xiaolei Liu, MD & PhD

Role: CONTACT

ring@vip.163.com

+86 10 83198650

Other Identifiers

DBS for TRD

Identifier Type: -

Identifier Source: org_study_id