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

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ClinicalTrials.gov Identifier: NCT03463590
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bomin Sun, Ruijin Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: Bilateral surgical implantation of DBS system to habenula Not Applicable

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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: Deep Brain Stimulation of the Bilateral Habenula for Treatment-Refractory Obsessive-Compulsive Disorder
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Y-BOCSII Score [ Time Frame: Baseline (preoperative),1 month, 3 months,6 months, 9 months ]
    The score of the scale ranges from 0 to 50

  2. Change in OCI-R Score [ Time Frame: Baseline (preoperative),1 month, 3 months,6 months, 9 months ]
    The score of the scale ranges from 0 to 72


Secondary Outcome Measures :
  1. changes in the Hamilton Depression Scale(HAMD-17) [ Time Frame: Baseline(preoperative),1 month, 3 months, 6 months,9 months ]
    The score of the scale ranges from 0 to 50

  2. changes in the Hamilton Anxiety Scale(HAMA-14) [ Time Frame: Baseline(preoperative),1 month, 3 months, 6 months,9 months ]
    The score of the scale ranges from 0 to 56

  3. changes in FMRI signal [ Time Frame: Baseline(preoperative),3 month, 6 months, 9 months ]
    The FMRI signal is to estimate Blood Oxygenation Level Dependent (BOLD) and connectivity of brain areas

  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) [ Time Frame: Baseline(preoperative),1 month, 3months,6months,9months ]
    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



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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:

  • 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:

  • 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.

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): NCT03463590


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

Locations
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China, Shanghai
Shanghai Ruijin Hospital Functional Neurosurgery Recruiting
Shanghai, Shanghai, China, 200025
Contact: Chencheng Zhang, MD    +086-18217122884    i@cczhang.org   
Contact: Yingying Zhang, MSc    +086-17602137369    zhyy019@126.com   
Sponsors and Collaborators
Ruijin Hospital

Publications:

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Responsible Party: Bomin Sun, Director of the Department of Functional Neurosurgery, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03463590     History of Changes
Other Study ID Numbers: Habenula DBS for OCD
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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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:
Habenula
Obsessive-Compulsive Disorder
Deep brain stimulation
Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders