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Trial record 42 of 1762 for:    depression AND Major Depression AND Scale | "Depression"

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

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ClinicalTrials.gov Identifier: NCT03254017
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bomin Sun, 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.


Condition or disease Intervention/treatment Phase
Treatment Resistant Major Depressive Disorder Procedure: Bilateral surgical implantation of DBS system to Habeluna Other: Follow-up Period Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: all subjects will receive bilateral surgical implantation of DBS system.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remotely Programmed Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression: An Open Label Pilot Trial
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Deep Brain Stimulation
Device:Suzhou Sceneray® DBS system
Procedure: Bilateral surgical implantation of DBS system to Habeluna
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.

Other: Follow-up Period
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.




Primary Outcome Measures :
  1. 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 ]
  2. Change in the Hamilton Depression Scale [ Time Frame: Baseline(preoperative),3 months, 6 months,9 months, 12months ]

Secondary Outcome Measures :
  1. Change in the Hamilton Anxiety Scale [ Time Frame: Baseline(preoperative),3 months, 6 months,9 months, 12months ]
  2. Change in the Quality of Life Assessment (SF-36) [ Time Frame: Baseline(preoperative),3 months, 6 months,9 months, 12 months ]
  3. Neuropsychological measures(Scores of cogstate battery) [ Time Frame: Baseline(preoperative),6 months,12 months ]
  4. Change in the Hamilton Anxiety Scale [ Time Frame: Baseline(preoperative),3 months, 6 months,9 months, 12 months ]
  5. Change in the WHO-BREF [ Time Frame: Baseline(preoperative),3 months,6 months,9 months, 12 months ]
  6. 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 ]
  7. Chang in Pittsburgh Sleep Quality Index [ Time Frame: Baseline(preoperative),3 months,6 months,9 months, 12 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254017


Contacts
Contact: Chencheng Zhang, MD +086-18217122884 i@cczhang.org

Locations
China, Shanghai
Shanghai Ruijin Hospital Functional Neurosurgery Recruiting
Shanghai, Shanghai, China, 200025
Contact: Chencheng Zhang, MD       i@cczhang.org   
Contact: Yingying Zhang, MSc       zhyy@126.com   
Shanghai Ruijin Hospital Functional Neurosurgery Recruiting
Shanghai, Shanghai, China
Contact: Chencheng Zhang, MD       i@cczhang.org   
Contact: Yingying Zhang, MSc       zhyy@126.com   
Sponsors and Collaborators
Ruijin Hospital

Publications:

Responsible Party: Bomin Sun, Director of the Department of Functional Neurosurgery, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03254017     History of Changes
Other Study ID Numbers: Habenula DBS
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bomin Sun, Ruijin Hospital:
Bilateral Habeluna
Remote Deep Brain Stimulation
Treatment Resistant Major Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders