NCT03667872

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Beijing Pins Medical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Depressive Disorder

Interventions

Type	Name	Description
PROCEDURE	Bilateral implantation of DBS system to Habeluna	Bilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-06-18
• Completion: 2022-06-18
• First posted: 2018-09-12
• Last updated: 2018-12-27

Locations

1 site across 1 country: China