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

Shanghai Jiao Tong University

Status

Terminated

Conditions

Treatment Resistant Major Depressive Disorder

Treatments

Procedure: Bilateral surgical implantation of DBS system to Habeluna

Other: Follow-up Period

Study type

Interventional

Funder types

Other

Identifiers

NCT03254017

Habenula DBS

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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;