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

NCT03463590 | Unknown

• 1 other identifier: Habenula DBS for OCD
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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. 1.The lateral habenula DBS has significant clinical antidepressant effects.
2. 2.The habenula plays an important role in the regulation of dopamine and serotonin systems.
3. 3.Selective serotonin reuptake inhibitors, the first line treatment for OCD, are commonly used to treat clinical depression.
4. 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. 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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Habenula; Obsessive-Compulsive Disorder; Deep brain stimulation

Outcome Measures

Primary Outcomes (2)

• Change in Y-BOCSII Score

  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

  The score of the scale ranges from 0 to 72

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

Secondary Outcomes (6)

• changes in the Hamilton Depression Scale(HAMD-17)

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

• changes in the Hamilton Anxiety Scale(HAMA-14)

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

• changes in FMRI signal

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

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

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

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

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

Study Arms (1)

DBS

EXPERIMENTAL

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

Bilateral surgical implantation of DBS system to habenula DEVICE

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

DBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital Functional Neurosurgery

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 26208305 BACKGROUND

• 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.

  PMID: 29406245 BACKGROUND

• 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.

  PMID: 28384832 BACKGROUND

• 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.

  PMID: 28576510 BACKGROUND

• 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.

  PMID: 28223096 BACKGROUND

• 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.

  PMID: 25476971 BACKGROUND

• 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.

  PMID: 27527822 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Yingying Zhang, MSc

CONTACT

+086-17602137369; zhyy019@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Functional Neurosurgery

Model Details: All subjects will receive bilateral surgical implantation of DBS system

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 13, 2018
• Study Start: March 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

CN (1)