Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder

Novel Deep Brain Stimulation in Ventral Capsule and Stratum for Refractory Obsessive-Compulsive Disorder: A Pilot Study

Refractory obsessive-compulsive disorder (OCD) is a disabling condition. Deep brain stimulation (DBS) of ventral capsule/ventral striatum(VC/VS) is potentially the most effective treatment for refractory OCD. However, the affecting area of traditional electrodes is limited and not specific to VC/VS. The investigators designed a novel electrode, 2 mental contacts(3mm contact-2mm space-3 mm contact) could be implanted in ventral striatum and the other upper 2 contacts(4mm space-3mm contact-4mm space-3mm contact)that can be implanted in ventral capsule simultaneously, which the investigators believe will be more effective due to better compatibly with anatomical features of target area. This trial is to evaluate the effectiveness and safety of this approach.

Study Overview

• Status: Unknown
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: deep brain stimulation system

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Chencheng Zhang, MD; Phone Number: +8618217122884; Email: i@cczhang.com
• Study Contact Backup: Name: Chencheng Zhang, MD; Phone Number: +8618217122884; Email: i@cczhang.org

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Shanghai Ruijin Hospital
      • Contact: Chencheng Zhang, MD; Phone Number: +86 18217122884; Email: i@cczhang.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 18 and 65 years.
2. A primary diagnosis of OCD, defined according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V).
3. Chronic: at least a 3-year history of OCD symptoms with psychosocial dysfunction
4. Severity: a score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of more than 25 or one subscale score of more than 15 ; a score for severity of illness on the Clinical Global Impression (CGI) scale of more than 4.
5. Disability: a score on the Global Assessment Functioning (GAF) scale of less than 45 or a score on Sheehan Disability Scale more than 24.
6. Refractory: a lack of response to drug therapy after adequate administration, defined as more than two types of serotonin reuptake inhibitors at the maximum tolerated dose for more than 12 weeks. Adequate behavior therapy, defined as more than 20 sessions psychotherapy with experienced therapist.
7. OCD medication regimen is stable for at least 4 weeks before enrollment.

Exclusion Criteria:

1. Schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the Mini-International Neuropsychiatric Interview (MINI 6.0.0).
2. Cluster A or B personality disorder according to DSM-IV-TR criteria, as assessed with the use of the Structured Clinical Interview II.
3. A current severe major depressive episode, determined according to DSM-V criteria (as assessed with the use of the MINI 6.0.0) and defined by the Hamilton Depression Rating Scale-17 (HAMD) score of more than 20 and a risk of suicide.
4. Abnormal cognitive status (measured by MoCA), abnormal findings on functional magnetic resonance imaging (MRI) of the brain, or contraindications to surgery or anesthesia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active stimulation; Stimulator on followed by off	Device: deep brain stimulation system
Sham Comparator: Sham stimulation; Stimulator off followed by on	Device: deep brain stimulation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score	Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Obsessive-Compulsive Inventory - Revised (OCI-R) Score	Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Adverse Events	Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score	Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Functional magnetic resonance imaging (fMRI) images	Baseline (preoperative)
Quality of life: Global assessment of function	Baseline (preoperative), 8 months, 12 months, 24 month
Disability: WHO disability assessment 2.0	Baseline (preoperative), 8 months, 12 months, 24 month
Neurobehavior Task (Decision making task, such as Model task, IGT)	Baseline (preoperative), 8 months, 12 months, 24 month
Neurobehavior Task (Working memory task, such as N-back)	Baseline (preoperative), 8 months, 12 months, 24 month
Disability: Sheehan Disability Scale	Baseline (preoperative), 8 months, 12 months, 24 month
Change in Obsessional beliefs questionnaire (OBQ-44) Score	Baseline (preoperative), 1 month, 3 months, 5 months, 6 months, 8 months, 12 months, 18 month, 24 month
Change in Adult Temperament Questionnaire (ATQ-77) Score	Baseline (preoperative), 8 months, 12month, 24 month
Change in Temperament and Character Inventory Revised (TRI-R) Score	Baseline (preoperative), 8 months, 12month, 24 month
Cerebral glucose metabolism measured by PET-CT images	Baseline (preoperative), 12 month

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Publications and helpful links

General Publications

• Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum In: N Engl J Med. 2009 Sep 3;361(10):1027.
• Goodman WK, Foote KD, Greenberg BD, Ricciuti N, Bauer R, Ward H, Shapira NA, Wu SS, Hill CL, Rasmussen SA, Okun MS. Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Biol Psychiatry. 2010 Mar 15;67(6):535-42. doi: 10.1016/j.biopsych.2009.11.028. Epub 2010 Feb 8.
• Denys D, Mantione M, Figee M, van den Munckhof P, Koerselman F, Westenberg H, Bosch A, Schuurman R. Deep brain stimulation of the nucleus accumbens for treatment-refractory obsessive-compulsive disorder. Arch Gen Psychiatry. 2010 Oct;67(10):1061-8. doi: 10.1001/archgenpsychiatry.2010.122.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: OCD pilot