Deep Electrical Neuromodulation in Obsessive-compulsive Disorder

NCT03605316 | Completed

• 1 other identifier: RECHMPL18_0141
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obsessive-compulsive Disorder (OCD)

Keywords

Deep brain stimulation; obsessive-compulsive disorder; neuromodulation; psychiatry; quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).

  Baseline

• Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).

  12 months

Interventions

Deep brain stimulation (DBS) PROCEDURE

Neurosurgical treatment by stereotactic implantation of electrodes in the brain that affects the functioning of subcortical neuronal circuits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- already enrolled in a study protocol at time of implantation

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Fabienne CYPRIEN

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: July 30, 2018
• Study Start: April 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: June 30, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-04

Locations

FR (1)