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NCT Number: NCT03605316

Deep Electrical Neuromodulation in Obsessive-compulsive Disorder

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.

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Key information

Conditions

Obsessive-Compulsive Disorder (OCD) Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Brain Stimulation (DBS)

Procedure

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

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: Baseline

    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

  2. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: 12 months

    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

Secondary outcomes

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

    Time frame: Baseline

    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.

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

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: NEP-TOC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2018
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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