An interventional study of Bilateral surgical implantation of DBS system to Habeluna and Follow-up Period in Treatment Resistant Major Depressive Disorder, sponsored by Ruijin Hospital. Terminated at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-29.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Device：Suzhou Sceneray® DBS system
Procedure: Bilateral surgical implantation of DBS system to Habeluna · Other: Follow-up Period
The SceneRay DBS device utilized in the present study is a double-channel device designed and manufactured by Suzhou Scene-Ray Medical Co., Ltd. The DBS system includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller. The lead (diameter =1.27 mm) contains four stimulating contacts made of platinumiridium alloy. The length of each contact is 1.5 mm, and interval spaces are 0.5 mm. This device shares the same basic principles utilized by Medtronic products, with unique wireless programming and electrode fixing designs. The amplitude (0-10 V), pulse width (60-960 ms), and frequency (1-1,600 Hz) can be programmed, and different frequencies may be utilized in the left and right hemispheres using this type of dual-channel IPG.
The researchers will remotely program the DBS biweekly after opening the stimulator and face to face test the patients' cognitive function every half year. Montgomery-Asberg Depression Rating Scale will be tested biweekly until the Programmed parameter has stable therapeutic efficacy and then tested after 3 months, 6 months, 9 months and 12 months.The other neuropsychological scales will be test on 3 months, 6 months, 9 months and 12 months.
Change in the Montgomery-Asberg Depression Rating Scale
Time frame: Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months
Change in the Hamilton Depression Scale
Time frame: Baseline（preoperative）,3 months, 6 months,9 months, 12months
Change in the Hamilton Anxiety Scale
Time frame: Baseline（preoperative）,3 months, 6 months,9 months, 12months
Change in the Quality of Life Assessment (SF-36)
Time frame: Baseline（preoperative）,3 months, 6 months,9 months, 12 months
Neuropsychological measures(Scores of cogstate battery)
Time frame: Baseline（preoperative）,6 months,12 months
Change in the Hamilton Anxiety Scale
Time frame: Baseline（preoperative）,3 months, 6 months,9 months, 12 months
Change in the WHO-BREF
Time frame: Baseline（preoperative）,3 months,6 months,9 months, 12 months
Change in Young Manic Rating Scale
Time frame: Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months
Chang in Pittsburgh Sleep Quality Index
Time frame: Baseline（preoperative）,3 months,6 months,9 months, 12 months
This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital