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Treatment Resistant Major Depressive DisorderNCT03254017

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

A study testing Bilateral surgical implantation of DBS system to Habeluna and Follow-up Period in people with Treatment Resistant Major Depressive Disorder, run by Ruijin Hospital at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Bilateral surgical implantation of DBS system to Habeluna and Follow-up Period
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
2 sitesChina
Study dates
24 Jul 2017to 30 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Shanghai Ruijin Hospital Functional Neurosurgery

    Shanghai, Shanghai Municipality, 200025

  • Shanghai Ruijin Hospital Functional Neurosurgery

    Shanghai, Shanghai Municipality

Other trials in China

About this study

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.

Being tested
Bilateral surgical implantation of DBS system to Habeluna, Follow-up Period
Keywords
Bilateral Habeluna, Remote Deep Brain Stimulation, Treatment Resistant Major Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral surgical implantation of DBS system to HabelunaProcedure or surgery

    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.

  • Follow-up PeriodOther

    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.

Study groups in NCT03254017
Study groupRoleWhat they receive
Experimental Deep Brain StimulationExperimentalDevice：Suzhou Sceneray® DBS system
Receives: Procedure: Bilateral surgical implantation of DBS system to Habeluna; Other: Follow-up Period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Montgomery-Asberg Depression Rating Scale

    Measured: Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months

  2. Change in the Hamilton Depression Scale

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

Secondary outcomes (7)

  1. Change in the Hamilton Anxiety Scale

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

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

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

  3. Neuropsychological measures(Scores of cogstate battery)

    Measured: Baseline（preoperative）,6 months,12 months

  4. Change in the Hamilton Anxiety Scale

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

  5. Change in the WHO-BREF

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

  6. Change in Young Manic Rating Scale

    Measured: Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months

  7. Chang in Pittsburgh Sleep Quality Index

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2017
  2. Study start24 Jul 2017
  3. Primary completion30 Nov 2018
  4. Study completion30 Aug 2019

Why it stopped: logistics reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
all subjects will receive bilateral surgical implantation of DBS system.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03254017
Sponsor's protocol ID
Habenula DBS
Status last verified
Nov 2019
First submitted
16 Aug 2017
Last updated
29 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 19846068

  • 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.

    PubMed 23828711

  • 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.

    PubMed 28223096

  • 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.

    PubMed 25157511

  • 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.

    PubMed 27049915

  • 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.

    PubMed 28571034

  • 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.

    PubMed 27321195

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral surgical implantation of DBS system to Habeluna and Follow-up Period in people with Treatment Resistant Major Depressive Disorder, run by Ruijin Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: logistics reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03254017, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.

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