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

Primary Purpose

Treatment Resistant Major Depressive Disorder

Status

Terminated

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Bilateral surgical implantation of DBS system to Habeluna

Follow-up Period

About this trial

This is an interventional treatment trial for Treatment Resistant Major Depressive Disorder focused on measuring Bilateral Habeluna, Remote Deep Brain Stimulation, Treatment Resistant Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Shanghai Ruijin Hospital Functional Neurosurgery
Shanghai Ruijin Hospital Functional Neurosurgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Deep Brain Stimulation

Arm Description

Device：Suzhou Sceneray® DBS system

Outcomes

Primary Outcome Measures

Change in the Montgomery-Asberg Depression Rating Scale

Change in the Hamilton Depression Scale

Secondary Outcome Measures

Change in the Hamilton Anxiety Scale

Change in the Quality of Life Assessment (SF-36)

Neuropsychological measures(Scores of cogstate battery)

Change in the Hamilton Anxiety Scale

Change in the WHO-BREF

Change in Young Manic Rating Scale

Chang in Pittsburgh Sleep Quality Index

Full Information

NCT ID

NCT03254017

First Posted

August 16, 2017

Last Updated

November 26, 2019

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03254017

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Terminated

Why Stopped

logistics reasons

Study Start Date

July 24, 2017 (Actual)

Primary Completion Date

November 30, 2018 (Actual)

Study Completion Date

August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Resistant Major Depressive Disorder

Keywords

Bilateral Habeluna, Remote Deep Brain Stimulation, Treatment Resistant Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

all subjects will receive bilateral surgical implantation of DBS system.

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Deep Brain Stimulation

Arm Type

Experimental

Arm Description

Device：Suzhou Sceneray® DBS system

Intervention Type

Procedure

Intervention Name(s)

Bilateral surgical implantation of DBS system to Habeluna

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Follow-up Period

Intervention Description

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 Measure Information:

Title

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

Title

Change in the Hamilton Depression Scale

Time Frame

Baseline（preoperative）,3 months, 6 months,9 months, 12months

Secondary Outcome Measure Information:

Title

Change in the Hamilton Anxiety Scale

Time Frame

Baseline（preoperative）,3 months, 6 months,9 months, 12months

Title

Change in the Quality of Life Assessment (SF-36)

Time Frame

Baseline（preoperative）,3 months, 6 months,9 months, 12 months

Title

Neuropsychological measures(Scores of cogstate battery)

Time Frame

Baseline（preoperative）,6 months,12 months

Title

Change in the Hamilton Anxiety Scale

Time Frame

Baseline（preoperative）,3 months, 6 months,9 months, 12 months

Title

Change in the WHO-BREF

Time Frame

Baseline（preoperative）,3 months,6 months,9 months, 12 months

Title

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

Title

Chang in Pittsburgh Sleep Quality Index

Time Frame

Baseline（preoperative）,3 months,6 months,9 months, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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;

Facility Information:

Facility Name

Shanghai Ruijin Hospital Functional Neurosurgery

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Shanghai Ruijin Hospital Functional Neurosurgery

City

Shanghai

State/Province

Shanghai

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

19846068

Citation

Sartorius A, Kiening KL, Kirsch P, von Gall CC, Haberkorn U, Unterberg AW, Henn FA, Meyer-Lindenberg A. Remission of major depression under deep brain stimulation of the lateral habenula in a therapy-refractory patient. Biol Psychiatry. 2010 Jan 15;67(2):e9-e11. doi: 10.1016/j.biopsych.2009.08.027. No abstract available.

Results Reference

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PubMed Identifier

23828711

Citation

Kiening K, Sartorius A. A new translational target for deep brain stimulation to treat depression. EMBO Mol Med. 2013 Aug;5(8):1151-3. doi: 10.1002/emmm.201302947. Epub 2013 Jul 4. No abstract available.

Results Reference

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PubMed Identifier

28223096

Citation

Fakhoury M. The habenula in psychiatric disorders: More than three decades of translational investigation. Neurosci Biobehav Rev. 2017 Dec;83:721-735. doi: 10.1016/j.neubiorev.2017.02.010. Epub 2017 Feb 13.

Results Reference

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PubMed Identifier

25157511

Citation

Proulx CD, Hikosaka O, Malinow R. Reward processing by the lateral habenula in normal and depressive behaviors. Nat Neurosci. 2014 Sep;17(9):1146-52. doi: 10.1038/nn.3779.

Results Reference

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PubMed Identifier

27049915

Citation

Bergfeld IO, Mantione M, Hoogendoorn ML, Ruhe HG, Notten P, van Laarhoven J, Visser I, Figee M, de Kwaasteniet BP, Horst F, Schene AH, van den Munckhof P, Beute G, Schuurman R, Denys D. Deep Brain Stimulation of the Ventral Anterior Limb of the Internal Capsule for Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):456-64. doi: 10.1001/jamapsychiatry.2016.0152.

Results Reference

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PubMed Identifier

28571034

Citation

Li D, Zhang C, Gault J, Wang W, Liu J, Shao M, Zhao Y, Zeljic K, Gao G, Sun B. Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System. Stereotact Funct Neurosurg. 2017;95(3):174-182. doi: 10.1159/000475765. Epub 2017 Jun 2.

Results Reference

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PubMed Identifier

27321195

Citation

Zhang C, Li D, Zeljic K, Tan H, Ning Y, Sun B. A Remote and Wireless Deep Brain Stimulation Programming System. Neuromodulation. 2016 Jun;19(4):437-9. doi: 10.1111/ner.12448. No abstract available.

Results Reference

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

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