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

March 27, 2018 updated by: Bomin Sun, Ruijin Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Ruijin Hospital Functional Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (preoperative),1 month, 3 months,6 months, 9 months
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
Baseline (preoperative),1 month, 3 months,6 months, 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline（preoperative）,1 month, 3 months, 6 months,9 months
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
Baseline（preoperative）,1 month, 3 months, 6 months,9 months
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
Baseline（preoperative）,3 month, 6 months, 9 months
changes in World Health Organization Quality of Life-BREF(WHO-BREF)
Time Frame: Baseline（preoperative）,1 month, 3 months,6 months,9 months
Baseline（preoperative）,1 month, 3 months,6 months,9 months
changes the MOS item short from health survey (SF-36)
Time Frame: Baseline（preoperative）,1 month, 3 months,6 months,9 months
Baseline（preoperative）,1 month, 3 months,6 months,9 months
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
Baseline（preoperative）,1 month, 3months,6months,9months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

February 28, 2020

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Habenula DBS for OCD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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