Comparison of DBS Targets in Obsessive-compulsive Disorder

NCT ID: NCT01807403

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-02-29

Brief Summary

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.

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Deep brain stimulation of subthalamic nucleus

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus

Group Type: EXPERIMENTAL

Deep brain stimulation

Intervention Type: PROCEDURE

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.

Deep brain stimulation of caudate nucleus

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation

Group Type: EXPERIMENTAL

Deep brain stimulation

Intervention Type: PROCEDURE

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.

Deep brain stimulation of nucleus accumbens

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.

Group Type: EXPERIMENTAL

Deep brain stimulation

Intervention Type: PROCEDURE

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.

Interventions

Deep brain stimulation

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luc Mallet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assitance Publique - Hopitaux de Paris

Locations

Centre d'investigation Clinique Pitié Salpêtrière

Paris, , France

Countries

France

Other Identifiers

P081203

Identifier Type: -

Identifier Source: org_study_id