Deep Brain Stimulation and Obsessive-compulsive Disorder (STOC2)

February 5, 2020 updated by: University Hospital, Bordeaux

Treatment of Severe and Resistant Obsessive-compulsive Disorder by High-frequency Stimulation of the Ventral Striatum and the Subthalamic Nucleus

Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition, which is classically treated by antidepressant medications in combination with psychotherapies. However, both these conventional therapeutic approaches fail to sufficiently improve obsessive-compulsive symptoms in 20-30% of cases. From these considerations, deep brain stimulation (DBS), as a reversible and adjustable surgical procedure, has recently been introduced in the field of resistant OCD. DBS currently uses electrodes with four contacts on each lead, which are bilaterally implanted into the chosen brain structure. DBS consists of the delivery of a high-frequency current through the quadripolar electrodes connected to a battery powered pulse-generating device. Several clinical investigations have shown that DBS, primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN), as brain sites of interest because of their particular involvement in the production of OCD symptoms, is able to produce an approximately 40% or greater reduction in clinical symptom intensity in severely chronic and incapacitating forms of OCD. These promising findings lead to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the VS or STN as brain target by conducting a large controlled trial and including a medico-economic analysis for assessing the classical cost/efficacy ratio. In this way, the present study is expected to promote and highlight the importance of DBS, as an effective, safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition with an estimated lifetime prevalence of 2-3 % of the general population. It is generally characterized by a chronic course leading to a profound impairment in psychosocial functioning and to a marked deterioration in quality of life. Today, the well-established efficacy of antidepressants, acting preferentially by blocking serotonin reuptake, in addition to psychological treatments, have considerably changed the poor prognosis of the illness. However, both conventional therapeutic approaches failed to substantially alleviate obsessive-compulsive symptoms in 20-30% of cases. Deep brain stimulation, as a reversible and adjustable surgical procedure, has recently been introduced in the field of OCD, primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN) and leading to an approximately 40% or greater reduction in clinical symptom intensity from baseline levels in severely chronic and resistant forms of OCD. These promising findings lead to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the VS or STN as brain target by conducting a multicenter, parallel-group, randomized, single-blind trial over a 13-month follow-up period. For this purpose, a total population of 28 OCD patients who meet the currently used operational criteria for defining therapeutic resistance will be recruited. The surgical procedure will consist in the implantation of stimulation electrodes with four contacts on each lead, which are stereotactically and bilaterally implanted into the targeted brain structure under local anesthesia. Per-operative, single-unit electrophysiological recordings of the neuronal activity will be performed using five parallel microelectrodes and serving as guide for the implantation of both definitive electrodes. They will be connected to a battery powered pulse-generating device five days later under general anesthesia. Thereafter, psychiatric assessments including both the Y-BOCS ("Yale-Brow Obsessive-compulsive scale") and PI ("Padua Inventory") for measuring OCD symptom severity, the BAS ("Brief Anxiety Scale"), MADRS ("Montgomery and Asberg Depression rating Scale") and HAD ("Hospital Anxiety and Depression Scale") for determining anxiety and/or depressive symptom intensity, and the CGI ("Clinical Global Impression") rating scales for evaluating global symptom severity and treatment response will be performed every 3 months beyond the one-month postoperative free-stimulation period. This will be coupled with a large battery of neuropsychological tests exploring all executive functions in combination with precise medical records of side effects for appreciating safety/tolerability of DBS. A cost-effectiveness analysis, as a formal method of comparing DBS and classical therapeutic strategies with regard to their respective resource utilization (costs) and outcomes (effectiveness) will also be carried out. Therefore, the present study may contribute to highlight the special interest of DBS, as an effective, safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Bordeaux University Hospital
      • Clermont-Ferrand, France, 63003
        • Clermont-Ferrand University Hospital
      • Créteil, France, 94010
        • Henri Mondor Hospital
      • Grenoble, France, 38043
        • Grenoble University Hospital
      • Lille, France, 59037
        • Lille University Hospital
      • Lyon, France, 69229
        • Lyon University Hospital
      • Marseille, France, 13385
        • Marseille University Hospital
      • Nice, France, 06202
        • Nice University Hospital
      • Paris, France, 75651
        • Pitié-Salpêtrière Hospital
      • Paris, France, 75674
        • Sainte-Anne Hospital
      • Poitiers, France, 86021
        • Poitiers University Hospital
      • Rennes, France, 35033
        • Rennes University Hospital
      • Strasbourg, France, 67091
        • Strasbourg University Hospital
      • Toulouse, France, 31059
        • Toulouse University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age comprised between 18 and 60 years
  • History of OCD for at least 5 years according to the DSM-IV-TR criteria and characterized by a "good insight", as determined by the BABS ("Brown Assessment of Beliefs Scale")

  • Severe form of OCD, as evidenced by:

    • a score ≥ 25 on the Y-BOCS
    • a score > 4 on the CGI scale
    • a score =< 40 on the GAF ("global assessment of functioning)
  • Lack of therapeutic effects of at least 3 antidepressants selectively blocking serotonin reuptake (SSRI) at least 12 consecutive weeks at the maximal tolerated dose (up to 80 mg/day for fluoxetine, 300 mg/day for fluvoxamine, 200 mg/day for sertraline, 60 mg/day for paroxetine, 60mg/day for citalopram and 250 mg/day for clomipramine) prescribed alone and in combination for at least 1 month with: 1) risperidone or olanzapine or aripiprazole or quetiapine, 2) clomipramine
  • Lack of therapeutic effects of behavioral therapy with two different therapists using conventional techniques primarily based on exposure with prevention of ritualized response
  • Understand and accept the design and constraints of the present study
  • Be a beneficiary or member of health insurance plan
  • Provide written consent to the study after receiving clear information

Exclusion Criteria:

  • Patient with cognitive impairment with a Mattis scale score ≤ 130
  • Patient with other DSM-IV-TR axis I diagnoses (schizophrenia, bipolar, substance abuse or substance dependence), except for generalized anxiety disorder, social phobia or nicotine dependence
  • Patient with high suicide risk, as indicated by a score ≥ 2 on the MADRS (item 10)
  • Patient with personality disorder corresponding to the clusters A and B, as assessed with the SIDP-IV ("Structured Interview for DSM-IV Personality")
  • Patient with contraindication for MRI scanning, abnormal brain MRI or serious intercurrent disease
  • Patient with contraindication for surgery or anesthesia
  • Patient currently treated with anticoagulant or antiplatelet drug
  • Be a woman of childbearing age without effective contraception
  • Be hospitalized under constraint
  • Be under guardianship procedures
  • Prohibition on participation in other research, apart from any other non-interventional research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: DBS of subthalamic nucleus
Procedure: Deep Brain Stimulation (DBS)
In a first time: Implantation of DBS electrodes, stereotactically, in each hemisphere into the targeted brain structure under local anesthesia. In a second time (next week): installation of the deep brain neurostimulator and connection to the electrodes implanted under general anesthesia. And one month later: beginning of the stimulation.
Active Comparator: DBS of ventral striatum
Procedure: Deep Brain Stimulation (DBS)
In a first time: Implantation of DBS electrodes, stereotactically, in each hemisphere into the targeted brain structure under local anesthesia. In a second time (next week): installation of the deep brain neurostimulator and connection to the electrodes implanted under general anesthesia. And one month later: beginning of the stimulation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Combination of three criteria (composite criterion), as follows: a. Y-BOCS score ≤ 16 / and b. Technical feasibility (each leads in the target) / and c. Safety, as assessed by any serial adverse event
Time Frame: Month 13 : one year after stimulation
Month 13 : one year after stimulation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Remission as defined by a Y-BOCS score ≤ 16 at M13
Time Frame: Month 13 : one year after stimulation
Month 13 : one year after stimulation
Number of electrode contacts correctly located within the chosen brain target (0, 1 or 2)
Time Frame: End of surgical procedure (day 1)
End of surgical procedure (day 1)
Monitoring of psychological and somatic complaints made spontaneously by the patient over the course of the present trial, in combination to the semi-structured interview for collecting side effects
Time Frame: Every 3 months from Month 1 to Month 13
Every 3 months from Month 1 to Month 13
Scores on neuropsychological tests exploring all executive functions
Time Frame: Every 3 months from Month 1 to Month 13
Every 3 months from Month 1 to Month 13
Percentage change in the total Y-BOCS score from M1 to M13
Time Frame: Every 3 months from Month 1 to Month 13
Every 3 months from Month 1 to Month 13
Therapeutic response, as indicated by a 35% decrease or more in the Y-BOCS score and a score of 1 or 2 (very much or much improved) on the CGI improvement scale from M1 to M13
Time Frame: Every 3 months from Month 1 to Month 13
Every 3 months from Month 1 to Month 13
Percentage change in the Y-BOCS obsessive and compulsive subscores from M1 to M13
Time Frame: Every 3 months from Month 1 to Month 13
Every 3 months from Month 1 to Month 13
Percentage change in the overall Padua Inventory score, MADRS score, BAS score from M1 to M13
Time Frame: Every 3 months from Month 1 to Month 13
Every 3 months from Month 1 to Month 13
Percentage change in the total and depression and anxiety subscale scores on the HAD scale from M1 and M13
Time Frame: Every 3 months from Month 1 to Month 13
Every 3 months from Month 1 to Month 13
Ratings of functional disability and quality of life
Time Frame: Every 3 months from Month 1 to Month 13
Every 3 months from Month 1 to Month 13
Correlations between efficacy and anatomical positioning of both stimulation electrodes within the chosen brain target
Time Frame: Every 3 months from Month 1 to Month 13
Every 3 months from Month 1 to Month 13
cost comparison of therapeutic strategies
Time Frame: M-13 and M13 (one year after stimultaion)
cost comparison of thérapeutic strategies : classical versus surgical
M-13 and M13 (one year after stimultaion)
Cost / effectiveness ration
Time Frame: M-13/ M13 (one year after stimulation)
Cost / effectiveness ratio : cost difference between therapeutic strategies and success rate of DBS
M-13/ M13 (one year after stimulation)
Cost-utility rati
Time Frame: every 3 months from month 1 to month 13
Cost-utility ratio based on SF-36 scores.
every 3 months from month 1 to month 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: BENARD Antoine, MD, University Hospital Bordeaux, France
  • Principal Investigator: Emmanuel CUNY, MD, University Hospital Bordeaux, France
  • Principal Investigator: Bruno AOUIZERATE, MD-PhD, Charles Perrens hospital, Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2010/43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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