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Obsessive-Compulsive DisorderNCT03463590

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

A study testing Bilateral surgical implantation of DBS system to habenula in people with Obsessive-Compulsive Disorder, run by Ruijin Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Bilateral surgical implantation of DBS system to habenula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
1 Mar 2018to 28 Feb 2020
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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Yingying Zhang, MSc contact

+086-17602137369

zhyy019@126.com

China1 site, 1 recruiting

  • Shanghai Ruijin Hospital Functional Neurosurgery

    Shanghai, Shanghai Municipality, 200025

    Chencheng Zhang, MD, +086-18217122884, i@cczhang.org

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

    Recruiting

Other trials in China

About this study

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.

Being tested
Bilateral surgical implantation of DBS system to habenula
Keywords
Habenula, Obsessive-Compulsive Disorder, Deep brain stimulation
Medical subject headings
Obsessive-Compulsive 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 habenulaDevice

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

Study groups in NCT03463590
Study groupRoleWhat they receive
DBSExperimentalAll subjects will undergo bilateral surgical implantation of DBS system to habenula. The DBS system will be active at one week after surgery.
Receives: Device: Bilateral surgical implantation of DBS system to habenula

What is being measured

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

  1. Change in Y-BOCSII Score

    The score of the scale ranges from 0 to 50

    Measured: 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

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

Secondary outcomes (6)

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

    The score of the scale ranges from 0 to 50

    Measured: 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

    Measured: 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

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

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

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

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

    Measured: 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

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

Timeline

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

  1. First posted13 Mar 2018
  2. Study start1 Mar 2018
  3. Primary completion28 Feb 2020 (estimated)
  4. Study completion28 Feb 2020 (estimated)

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
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03463590
Sponsor's protocol ID
Habenula DBS for OCD
Status last verified
Mar 2018
First submitted
28 Feb 2018
Last updated
29 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral surgical implantation of DBS system to habenula in people with Obsessive-Compulsive Disorder, run by Ruijin Hospital at 1 site 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Yingying Zhang, MSc (+086-17602137369, zhyy019@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Y-BOCSII Score (time frame: Baseline (preoperative),1 month, 3 months,6 months, 9 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 NCT03463590, 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 Mar 2018.

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