Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders
1 other identifier
interventional
16
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2005
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMarch 22, 2018
March 1, 2018
September 12, 2005
March 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Yale-Brown-Obession and Compulsion Scale (YBOCS)
YBOCS
2 three-month periods
Secondary Outcomes (20)
Global assessment of function (GAF)
10 month follow-up but 2 3-month period for the cross-over
Clinical Global Impression(CGI)
10 month follow-up but 2 3-month period for the cross-over
Montgomery and Asberg Depression Rating scale (MADRS)
10 month follow-up but 2 3-month period for the cross-over
Hospital Anxiety Depression scale (HAD-S)
10 month follow-up but 2 3-month period for the cross-over
Sheehan Disability Scale (SDS)
10 month follow-up but 2 3-month period for the cross-over
- +15 more secondary outcomes
Study Arms (2)
Group A
ACTIVE COMPARATORDeep brain stimulation on followed by off
Group B
SHAM COMPARATORNo stimulation, deep brain stimulation off followed by on
Interventions
Eligibility Criteria
You may qualify if:
- Severe obsessive-compulsive disorder
You may not qualify if:
- Contraindication to magnetic resonance imaging (MRI)
- Severe cognitive or behavioral disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marie-laure Welterlead
- Assistance Publique - Hôpitaux de Pariscollaborator
Study Sites (10)
Unknown Facility
Bordeaux, France
Unknown Facility
Clermont-Ferrand, France
Unknown Facility
Grenoble, France
Unknown Facility
Nantes, France
Unknown Facility
Nice, France
Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
Paris, France
Saint-Anne
Paris, France
Unknown Facility
Poitiers, France
Unknown Facility
Rennes, France
Unknown Facility
Toulouse, France
Related Publications (3)
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.
PMID: 20951978DERIVEDBourredjem 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.
PMID: 20621362DERIVEDMallet 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.
PMID: 19005196DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc Mallet, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
October 1, 2005
Study Completion
May 1, 2007
Last Updated
March 22, 2018
Record last verified: 2018-03