Remotely Programmed Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression: An Open Label Pilot Trial

Not Applicable

Terminated

• Conditions: Treatment Resistant Major Depressive Disorder
• Interventions: Procedure: Bilateral surgical implantation of DBS system to Habeluna; Other: Follow-up Period

• Registration Number: NCT03254017
• Lead Sponsor: Ruijin Hospital

Brief Summary

The habenula(Hb) is an epithalamic 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 indicates that that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive the changes in midbrain activity linked to depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical case of directly stimulating habeluna for treatment TRD. This research will investigate effectiveness bilateral DBS to habenula for patients with TRD.

Programming is a crucial aspect of DBS which directly influences its therapeutic efficacy. Researchers need to ascertain optimum stimulation parameters to help patients achieve optimal control of clinical symptoms. Remote programming of DBS can markedly improve patient convenience, minimize risk of infection and total treatment time and lead to an overall benefit for doctors and patients alike. This research will also investigate safety and benefit of remote programming of DBS.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-24
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-18
• Primary Completion: 2018-11-30
• Study Completion: 2019-08-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Age 18-65 years old
• Proficiency in Mandarin language;
• DSM-IV diagnosis of Majior depression disorder;
• Current episode duration ≥ 2 years;
• Failure to respond to a minimum of four different antidepressant treatments;
• Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode;
• Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria

• Schizophrenia or history of psychosis unrelated to MDD;
• Antisocial personality disorder, dementia, current tic disorder;
• Past stereotactic neurosurgical intervention;
• Alcohol or substance abuse/dependence within 6 months;
• Neurological disease (Abnormal PET-CT, MRI, EEG);
• Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator;
• Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases;
• Serious and unstable organic diseases (e.g. unstable coronal heart disease);
• HIV positive;
• Pregnancy and/or lactation;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Deep Brain Stimulation	Bilateral surgical implantation of DBS system to Habeluna	Device：Suzhou Sceneray® DBS system
Experimental Deep Brain Stimulation	Follow-up Period	Device：Suzhou Sceneray® DBS system

Primary Outcome Measures

Name	Time	Method
Change in the Montgomery-Asberg Depression Rating Scale	Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months
Change in the Hamilton Depression Scale	Baseline（preoperative）,3 months, 6 months,9 months, 12months

Secondary Outcome Measures

Name	Time	Method
Change in Young Manic Rating Scale	Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months
Change in the Hamilton Anxiety Scale	Baseline（preoperative）,3 months, 6 months,9 months, 12 months
Change in the Quality of Life Assessment (SF-36)	Baseline（preoperative）,3 months, 6 months,9 months, 12 months
Neuropsychological measures(Scores of cogstate battery)	Baseline（preoperative）,6 months,12 months
Change in the WHO-BREF	Baseline（preoperative）,3 months,6 months,9 months, 12 months
Chang in Pittsburgh Sleep Quality Index	Baseline（preoperative）,3 months,6 months,9 months, 12 months

Trial Locations

Locations (1)

Shanghai Ruijin Hospital Functional Neurosurgery; 🇨🇳 Shanghai, Shanghai, China