Deep Electrical Neuromodulation in Obsessive-compulsive Disorder (NEP-TOC)

Electric Neuromodulation in Refractory Obsessive-compulsive Disorder : the Montpellier Experience (France)

Obsessive-compulsive disorder (OCD) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions).

Its lifetime prevalence in the general population is usually estimated between 1 - 3% (Ruscio, Mol Psychiatry, 2010). Despite appropriate pharmacological and cognitive-behavioural treatments, it is commonly estimated that 10% of patients are therapy-refractory and that among improved or recovered patients, sustained efficacy is uncertain.

For treatment refractory OCD patients, a neurosurgical treatment by deep brain stimulation (DBS), has emerged in the late 1990s as a new therapeutic option (Nuttin et al, Lancet, 1999).

The objective of the current study is to report the long-term treatment effects (safety and effectiveness) of DBS from the cohort of six severe and therapy-refractory OCD patients implanted at the French university hospital of Montpellier since 2003.

Study Overview

• Status: Completed
• Conditions: Obsessive-compulsive Disorder (OCD)
• Intervention / Treatment: Procedure: Deep brain stimulation (DBS)

Detailed Description

The data needed to carry out the study will be extracted from the medical files of the 6 patients concerned.

The following data will be collected:

• Age, sex
• Medical, surgical and psychiatric history
• History of pharmacological treatments
• Elements from clinical examination
• any reported adverse effect
• scores of the various questionnaires completed throughout the follow-up (including Y-BOCS and GAF)
• results of biological, morphological, neuropsychological tests
• Stimulation parameters applied since implantation.

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Six patients consisting in three males and three females aged 18 years and over implanted at the University Hospital (CHU) of Montpellier (France) between June 2003 and February 2013.

Description

Inclusion criteria:

• all patients with severe and refractory OCD according to DSM-IV criteria, confirmed by experienced psychiatrist
• treated by DBS at the CHU of Montpellier

Exclusion criteria:

- already enrolled in a study protocol at time of implantation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms. Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS	Baseline
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms. Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).	a rating scale used to subjectively assess the social and occupational functioning as well as psychological symptoms of adults. The scale ranges from 1 to 100, divided into 10-point intervals describing the level of functioning and symptoms.	Baseline
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).	a rating scale used to subjectively assess the social and occupational functioning as well as psychological symptoms of adults. The scale ranges from 1 to 100, divided into 10-point intervals describing the level of functioning and symptoms.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Fabienne CYPRIEN, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: obsessive-compulsive disorder; quality of life; neuromodulation; psychiatry; Deep brain stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: RECHMPL18_0141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No