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

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
deep brain stimulation
No stimulation
Sponsored by
Marie-laure Welter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive compulsive disorder, deep brain stimulation, subthalamic nucleus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Severe obsessive-compulsive disorder Exclusion Criteria: Contraindication to magnetic resonance imaging (MRI) Severe cognitive or behavioral disorders

Sites / Locations

  • Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
  • Saint-Anne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group A

Group B

Arm Description

Deep brain stimulation on followed by off

No stimulation, deep brain stimulation off followed by on

Outcomes

Primary Outcome Measures

Yale-Brown-Obession and Compulsion Scale (YBOCS)
YBOCS

Secondary Outcome Measures

Global assessment of function (GAF)
GAF
Clinical Global Impression(CGI)
CGI
Montgomery and Asberg Depression Rating scale (MADRS)
MADRS
Hospital Anxiety Depression scale (HAD-S)
HAD-S
Sheehan Disability Scale (SDS)
SDS
Brief Scale for Anxiety (BABS)
BABS
Social Adjustment scale self-report (SAS-SR)
SAS-SR
neuropsychological tests
STROOP, apathy scales
adverse event
adverse event
Yale-Brown-Obession and Compulsion Scale (YBOCS)
Global assessment of function (GAF)
Clinical Global Impression(CGI)
Montgomery and Asberg Depression Rating scale (MADRS)
Hospital Anxiety Depression scale (HAD-S)
Sheehan Disability Scale (SDS)
Social Adjustment scale self-report (SAS-SR)
Quality of life (SF-36)
neuropsychological tests
adverse event
Stimulation parameters

Full Information

First Posted
September 12, 2005
Last Updated
March 20, 2018
Sponsor
Marie-laure Welter
Collaborators
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00169377
Brief Title
Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
Official Title
Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marie-laure Welter
Collaborators
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Obsessive compulsive disorder, deep brain stimulation, subthalamic nucleus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Deep brain stimulation on followed by off
Arm Title
Group B
Arm Type
Sham Comparator
Arm Description
No stimulation, deep brain stimulation off followed by on
Intervention Type
Procedure
Intervention Name(s)
deep brain stimulation
Intervention Description
Stimulator on followed by off
Intervention Type
Procedure
Intervention Name(s)
No stimulation
Intervention Description
Stimulator off followed by on
Primary Outcome Measure Information:
Title
Yale-Brown-Obession and Compulsion Scale (YBOCS)
Description
YBOCS
Time Frame
2 three-month periods
Secondary Outcome Measure Information:
Title
Global assessment of function (GAF)
Description
GAF
Time Frame
10 month follow-up but 2 3-month period for the cross-over
Title
Clinical Global Impression(CGI)
Description
CGI
Time Frame
10 month follow-up but 2 3-month period for the cross-over
Title
Montgomery and Asberg Depression Rating scale (MADRS)
Description
MADRS
Time Frame
10 month follow-up but 2 3-month period for the cross-over
Title
Hospital Anxiety Depression scale (HAD-S)
Description
HAD-S
Time Frame
10 month follow-up but 2 3-month period for the cross-over
Title
Sheehan Disability Scale (SDS)
Description
SDS
Time Frame
10 month follow-up but 2 3-month period for the cross-over
Title
Brief Scale for Anxiety (BABS)
Description
BABS
Time Frame
10 month follow-up but 2 3-month period for the cross-over
Title
Social Adjustment scale self-report (SAS-SR)
Description
SAS-SR
Time Frame
10 month follow-up but 2 3-month period for the cross-over
Title
neuropsychological tests
Description
STROOP, apathy scales
Time Frame
10 month follow-up but 2 3-month period for the cross-over
Title
adverse event
Description
adverse event
Time Frame
10 month follow-up but 2 3-month period for the cross-over
Title
Yale-Brown-Obession and Compulsion Scale (YBOCS)
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
Global assessment of function (GAF)
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
Clinical Global Impression(CGI)
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
Montgomery and Asberg Depression Rating scale (MADRS)
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
Hospital Anxiety Depression scale (HAD-S)
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
Sheehan Disability Scale (SDS)
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
Social Adjustment scale self-report (SAS-SR)
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
Quality of life (SF-36)
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
neuropsychological tests
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
adverse event
Time Frame
observational follow-up at 22 month, 34 month and 46 month
Title
Stimulation parameters
Time Frame
observational follow-up at 22 month, 34 month and 46 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe obsessive-compulsive disorder Exclusion Criteria: Contraindication to magnetic resonance imaging (MRI) Severe cognitive or behavioral disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Mallet, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
City
Bordeaux
Country
France
City
Clermont-Ferrand
Country
France
City
Grenoble
Country
France
City
Nantes
Country
France
City
Nice
Country
France
Facility Name
Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
City
Paris
Country
France
Facility Name
Saint-Anne
City
Paris
Country
France
City
Poitiers
Country
France
City
Rennes
Country
France
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20951978
Citation
Le Jeune F, Verin M, N'Diaye K, Drapier D, Leray E, Du Montcel ST, Baup N, Pelissolo A, Polosan M, Mallet L, Yelnik J, Devaux B, Fontaine D, Chereau I, Bourguignon A, Peron J, Sauleau P, Raoul S, Garin E, Krebs MO, Jaafari N, Millet B; French Stimulation dans le trouble obsessionnel compulsif (STOC) study group. Decrease of prefrontal metabolism after subthalamic stimulation in obsessive-compulsive disorder: a positron emission tomography study. Biol Psychiatry. 2010 Dec 1;68(11):1016-22. doi: 10.1016/j.biopsych.2010.06.033. Epub 2010 Oct 16.
Results Reference
derived
PubMed Identifier
20621362
Citation
Bourredjem A, Pelissolo A, Rotge JY, Jaafari N, Machefaux S, Quentin S, Bui E, Bruno N, Pochon JB, Polosan M, Baup N, Papetti F, Chereau I, Arbus C, Mallet L, du Montcel ST; French "Stimulation dans le Trouble Obsessionnel Compulsif (STOC)" Study Group. A video Clinical Global Impression (CGI) in obsessive compulsive disorder. Psychiatry Res. 2011 Mar 30;186(1):117-22. doi: 10.1016/j.psychres.2010.06.021. Epub 2011 Feb 12.
Results Reference
derived
PubMed Identifier
19005196
Citation
Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum In: N Engl J Med. 2009 Sep 3;361(10):1027.
Results Reference
derived

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

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