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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • 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

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
Intervention / Treatment
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

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

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

Marie-laure Welter

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

  • 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

October 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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