Comparison of DBS Targets in Obsessive-compulsive Disorder (PRESTOC2)

Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.

Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.

This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Procedure: Deep brain stimulation

Detailed Description

Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.

Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD patients. Efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Centre d'investigation Clinique Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• Age 18 - 60
• OCD according to DSM IV, at least 5 years since diagnosis
• Severe OCD responsible for a clinically significant and objective alteration of psychosocial functioning and suffering: YBOCS score>25, CGI score >= 4 and EGF score <= 40
• Resistance of OCD to at least 3 antidepressants from the serotonin reuptake inhibitors category, including clomipramine, given for at least 12 weeks with doses of at least 80mg/d for fluoxetine, 300mg/d for fluvoxamine, 200mg/d for sertraline, 60mg/d for paroxetine and citalopram, 250mg/d for clomipramine). Plus resistance to each of these 3 antidepressant associated first to risperidone or pimozide for a month then to Lithium carbonate, clonazepam, buspirone or pindolol for a month
• Resistance to at least 2 behavioural and cognitive therapies conducted by as many different specialists, following validated protocols (e.g. exposition and prevention of response)
• Oral and written knowledge of French
• Social security coverage
• Written consent of the patient after clear description of the study

Exclusion criteria :

• cognitive alteration with PM38 score < IQ85
• Other axis 1 disorder according to DSM IV, excepted, global anxiety disorder, social phobia, nicotine dependance, and antecedent of major depressive episodes
• suicidal risk >=2 on item 10 of MADRS (Montgomery Asberg Depression Rating Scale)
• Personality disorder (axis 2 of DSM IV assessed using the SCID II)
• Contra indication to MRI, abnormal brain MRI, other severe intercurrent disease
• Fertile woman without adequate contraception
• Pregnancy
• Forced psychiatric hospitalisation
• Any kind of legal protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep brain stimulation of subthalamic nucleus; Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus	Procedure: Deep brain stimulation; Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Experimental: Deep brain stimulation of caudate nucleus; Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation	Procedure: Deep brain stimulation; Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Experimental: Deep brain stimulation of nucleus accumbens; Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.	Procedure: Deep brain stimulation; Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	month 0
Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	6 months
Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	10 months
Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	14 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Luc Mallet, MD, PhD, Assitance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Subthalamic nucleus; Obsessive-Compulsive Disorder; Deep brain stimulation; Nucleus accumbens; Caudate nucleus
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: P081203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO