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Status unknownNCT03463590Updated Mar 29, 2018

Deep Brain Stimulation of the Bilateral Habenula for Treatment-Refractory Obsessive-Compulsive Disorder

An interventional study of Bilateral surgical implantation of DBS system to habenula in Obsessive-Compulsive Disorder, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Deep brain stimulation (DBS) offers an effective and safe treatment for patients with debilitating, otherwise treatment-refractory obsessive-compulsive disorder(OCD). Although several target areas for DBS have been used for OCD, such as the ventral capsule/ventral striatum and the subthalamic nucleus, not all patients show a clinical response, varying from 10% to 61.5%. Exploring new DBS targets may be a key approach to improve this situation. The habenula is an evolutionarily conserved structure playing an important role in depression, punishment avoiding, reward, addiction, pain and circadian rhythms. The habenula can be considered a promising target for OCD treatment based on the following hypotheses and clinical observations.

  1. The lateral habenula DBS has significant clinical antidepressant effects.
  2. The habenula plays an important role in the regulation of dopamine and serotonin systems.
  3. Selective serotonin reuptake inhibitors, the first line treatment for OCD, are commonly used to treat clinical depression.
  4. The habenula serves as a 'negative reward center' that mediates or moderates stress, negative emotions and thoughts, aversive learning, and goal-directed behavior, which are core clinical symptoms and signs of OCD.
  5. In our hospital, DBS of the habenula produced a significant improvement in OCD symptoms in one patient who failed to respond to other treatments, including capsulotomy either alone or in combination combined with cingulumotomy.

These theoretical and clinical considerations indicate that the habenula can be seen as a promising DBS target for OCD treatment. This study is focused on the effectiveness of bilateral DBS of the habenula for patients with treatment-refractory OCD. Furthermore, the study is aimed at exploring the influence of DBS of the habenula on brain activity and cognition.

02

Conditions studied

  • Obsessive-Compulsive Disorder

Keywords

  • Habenula
  • Obsessive-Compulsive Disorder
  • Deep brain stimulation
03

In context

Obsessive-Compulsive Disorder

626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.

This study's planned enrollment of 6 is below the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 668 studies on the registry; 377 are open to participants now.

Browse Ruijin Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed as having primary OCD according to DSM-IV criteria using the Structured Clinical Interview for DSM-IV Axis I disorders;
  • YBOCSII score ≥31；
  • Duration ≥2 years；
  • Refractoriness to therapy was defined as no response or insufficient response following at least 2 treatments with adequate trials or intolerance to two or three selective serotonin transporter inhibitors (SSRIs) and clomipramine, augmentation strategies (antipsychotics) and cognitive behavioral therapy.
  • Capacity to provide informed consent (understanding of the study purpose and methods.

Exclusion criteria

Exclusion Criteria:

  • Except for those with major depressive disorder and mild anxiety disorders, patients with clinically significant comorbid DSM-IV diagnoses (such as schizophrenia, bipolar II disorder, alcohol or substance abuse in the last 6 months, current tic disorder, or body dysmorphic disorder)
  • Patients with severe personality disorders, assessed using the Structured Clinical Interview for DSM-IV Axis II disorders.
  • Serious and unstable organic diseases (e.g. unstable coronal heart disease);
  • Pregnancy and/or lactation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    DBS

    All subjects will undergo bilateral surgical implantation of DBS system to habenula. The DBS system will be active at one week after surgery.

    Device: Bilateral surgical implantation of DBS system to habenula

Interventions

  • DeviceBilateral surgical implantation of DBS system to habenula

    The DBS device utilized in the present study may include the Medtronic, PINS and SceneRay DBS device depending on patients' choice.

06

What researchers measure

Primary outcomes

  1. Change in Y-BOCSII Score

    The score of the scale ranges from 0 to 50

    Time frame: Baseline (preoperative),1 month, 3 months,6 months, 9 months

  2. Change in OCI-R Score

    The score of the scale ranges from 0 to 72

    Time frame: Baseline (preoperative),1 month, 3 months,6 months, 9 months

Secondary outcomes

  1. changes in the Hamilton Depression Scale(HAMD-17)

    The score of the scale ranges from 0 to 50

    Time frame: Baseline（preoperative）,1 month, 3 months, 6 months,9 months

  2. changes in the Hamilton Anxiety Scale(HAMA-14)

    The score of the scale ranges from 0 to 56

    Time frame: Baseline（preoperative）,1 month, 3 months, 6 months,9 months

  3. changes in FMRI signal

    The FMRI signal is to estimate Blood Oxygenation Level Dependent (BOLD) and connectivity of brain areas

    Time frame: Baseline（preoperative）,3 month, 6 months, 9 months

  4. changes in World Health Organization Quality of Life-BREF(WHO-BREF)

    Time frame: Baseline（preoperative）,1 month, 3 months,6 months,9 months

  5. changes the MOS item short from health survey (SF-36)

    Time frame: Baseline（preoperative）,1 month, 3 months,6 months,9 months

  6. Neuropsychological measures(Scores of cogstate battery)

    Neuropsychological measures contains six tasks which are detection task, identification task, one card learning task, one back task, Groton maze learning task, set-shifting task

    Time frame: Baseline（preoperative）,1 month, 3months,6months,9months

07

Study locations

1 of 1 sites recruiting
  • Shanghai Ruijin Hospital Functional Neurosurgery
    Shanghai, Shanghai Municipality 200025, China
    Recruiting
08

References and documents

Publications

  • Alonso P, Cuadras D, Gabriels L, Denys D, Goodman W, Greenberg BD, Jimenez-Ponce F, Kuhn J, Lenartz D, Mallet L, Nuttin B, Real E, Segalas C, Schuurman R, du Montcel ST, Menchon JM. Deep Brain Stimulation for Obsessive-Compulsive Disorder: A Meta-Analysis of Treatment Outcome and Predictors of Response. PLoS One. 2015 Jul 24;10(7):e0133591. doi: 10.1371/journal.pone.0133591. eCollection 2015. PubMed 26208305 ↗
  • Kohl S, Baldermann JC. Progress and challenges in deep brain stimulation for obsessive-compulsive disorder. Pharmacol Ther. 2018 Jun;186:168-175. doi: 10.1016/j.pharmthera.2018.01.011. Epub 2018 Jan 31. PubMed 29406245 ↗
  • Hirschtritt ME, Bloch MH, Mathews CA. Obsessive-Compulsive Disorder: Advances in Diagnosis and Treatment. JAMA. 2017 Apr 4;317(13):1358-1367. doi: 10.1001/jama.2017.2200. PubMed 28384832 ↗
  • Batalla A, Homberg JR, Lipina TV, Sescousse G, Luijten M, Ivanova SA, Schellekens AFA, Loonen AJM. The role of the habenula in the transition from reward to misery in substance use and mood disorders. Neurosci Biobehav Rev. 2017 Sep;80:276-285. doi: 10.1016/j.neubiorev.2017.03.019. Epub 2017 May 30. PubMed 28576510 ↗
  • 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 ↗
  • Antolin-Fontes B, Ables JL, Gorlich A, Ibanez-Tallon I. The habenulo-interpeduncular pathway in nicotine aversion and withdrawal. Neuropharmacology. 2015 Sep;96(Pt B):213-22. doi: 10.1016/j.neuropharm.2014.11.019. Epub 2014 Dec 2. PubMed 25476971 ↗
  • Boulos LJ, Darcq E, Kieffer BL. Translating the Habenula-From Rodents to Humans. Biol Psychiatry. 2017 Feb 15;81(4):296-305. doi: 10.1016/j.biopsych.2016.06.003. Epub 2016 Jun 7. PubMed 27527822 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Feb 2020, 23 months after the start.

Of 230 non-industry interventional studies with no phase under Obsessive-Compulsive Disorder, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 68. This study's planned 23 months is below that.

Counting every sponsor, half of 232 studies reached it within 43 months; a quarter within 22 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2018
First posted
Mar 13, 2018
StartActual
Mar 1, 2018
Primary completionEst.
Feb 28, 2020
CompletionEst.
Feb 28, 2020
Last update
Mar 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03463590
Lead sponsor
Ruijin Hospital
Responsible party
Bomin Sun (Director of the Department of Functional Neurosurgery, Ruijin Hospital) — Principal investigator
First posted
Mar 13, 2018
Start date
Mar 1, 2018
Primary completion
Feb 28, 2020 (estimated)
Completion
Feb 28, 2020 (estimated)
Last update
Mar 29, 2018

Study contacts

Yingying Zhang, MSc
Contact
zhyy019@126.com
+086-17602137369

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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