Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)

March 20, 2018 updated by: Marie-laure Welter

Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders

Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency stimulation in patients with severe 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.

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.
16

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 2
  • Phase 1

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
      • Clermont-Ferrand, France
      • Grenoble, France
      • Nantes, France
      • Nice, France
      • Paris, France
        • Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
      • Paris, France
        • Saint-Anne
      • Poitiers, France
      • Rennes, France
      • Toulouse, France

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:

  • Severe obsessive-compulsive disorder

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging (MRI)
  • Severe cognitive or behavioral disorders

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: Crossover Assignment
  • Masking: Quadruple

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: Group A
Deep brain stimulation on followed by off
Procedure: deep brain stimulation
Stimulator on followed by off
Procedure: No stimulation
Stimulator off followed by on
Sham Comparator: Group B
No stimulation, deep brain stimulation off followed by on
Procedure: deep brain stimulation
Stimulator on followed by off
Procedure: No stimulation
Stimulator off followed by on

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
Measure Description
Time Frame
Yale-Brown-Obession and Compulsion Scale (YBOCS)
Time Frame: 2 three-month periods
YBOCS
2 three-month periods

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
Global assessment of function (GAF)
Time Frame: 10 month follow-up but 2 3-month period for the cross-over
GAF
10 month follow-up but 2 3-month period for the cross-over
Clinical Global Impression(CGI)
Time Frame: 10 month follow-up but 2 3-month period for the cross-over
CGI
10 month follow-up but 2 3-month period for the cross-over
Montgomery and Asberg Depression Rating scale (MADRS)
Time Frame: 10 month follow-up but 2 3-month period for the cross-over
MADRS
10 month follow-up but 2 3-month period for the cross-over
Hospital Anxiety Depression scale (HAD-S)
Time Frame: 10 month follow-up but 2 3-month period for the cross-over
HAD-S
10 month follow-up but 2 3-month period for the cross-over
Sheehan Disability Scale (SDS)
Time Frame: 10 month follow-up but 2 3-month period for the cross-over
SDS
10 month follow-up but 2 3-month period for the cross-over
Brief Scale for Anxiety (BABS)
Time Frame: 10 month follow-up but 2 3-month period for the cross-over
BABS
10 month follow-up but 2 3-month period for the cross-over
Social Adjustment scale self-report (SAS-SR)
Time Frame: 10 month follow-up but 2 3-month period for the cross-over
SAS-SR
10 month follow-up but 2 3-month period for the cross-over
neuropsychological tests
Time Frame: 10 month follow-up but 2 3-month period for the cross-over
STROOP, apathy scales
10 month follow-up but 2 3-month period for the cross-over
adverse event
Time Frame: 10 month follow-up but 2 3-month period for the cross-over
adverse event
10 month follow-up but 2 3-month period for the cross-over
Yale-Brown-Obession and Compulsion Scale (YBOCS)
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
Global assessment of function (GAF)
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
Clinical Global Impression(CGI)
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
Montgomery and Asberg Depression Rating scale (MADRS)
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
Hospital Anxiety Depression scale (HAD-S)
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
Sheehan Disability Scale (SDS)
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
Social Adjustment scale self-report (SAS-SR)
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
Quality of life (SF-36)
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
neuropsychological tests
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
adverse event
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month
Stimulation parameters
Time Frame: observational follow-up at 22 month, 34 month and 46 month
observational follow-up at 22 month, 34 month and 46 month

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.
Marie-laure Welter

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Assistance Publique - Hôpitaux de Paris

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.
  • Principal Investigator: Luc Mallet, MD, PhD, Assistance Publique - Hôpitaux de Paris

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

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.
October 1, 2005

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.
May 1, 2007

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).
September 12, 2005

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.
September 12, 2005

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.
September 15, 2005

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.
March 22, 2018

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.
March 20, 2018

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.
March 1, 2018

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.
  • P030422

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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