Quality of Life Improvement for Patients with Resistant OCD Using Deep Brain Stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of Deep Brain Stimulation (DBS) on patients with Obsessive-Compulsive Disorder (OCD) who have not responded to traditional treatments. It aims to assess not only the clinical improvement in symptoms but also the overall quality of life of participants, which is often overlooked in standard treatment evaluations. The study will also explore potential biomarkers that could predict which patients are most likely to benefit from DBS. By focusing on a larger cohort, the research seeks to validate the effectiveness of this innovative surgical approach in enhancing patients' functional status and well-being.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* OCD for \> 5 years
* YBOCS\> 25 and/or YBOCS sub-scale \>15
* GAF\< 45
* 3 or more documented SRI trials, including clomipramine (10-12 weeks at adequate dose)
* SRI augmentation for \> 4 weeks with at least one antipsychotic and with one of the following: lithium, clonazepam
* Adequate trial of CBT (Exposure Therapy and Response Prevention) (intolerance or \>15 sessions)
* Ability to provide informed consent

Exclusion Criteria:

* Hoarding (if the only OCD symptom)
* OCD with poor insight (BABS score \> 12)
* Lifetime diagnosis of psychosis or bipolar disorder;
* Substance abuse or dependence within the previous six months;
* Baseline Montgomery and Asberg (MADRS) suicidality item (item 10) score \>2;
* Current DSM-5 personality disorder of Cluster A (e.g., paranoid or schizotypal personality disorder) or B (e.g., borderline or antisocial personality disorder);
* Brain pathology, such as moderate or marked cerebral atrophy, stroke, tumor or previous neurosurgical procedures (i.e. capsulotomy etc), history of cognitive impairment and cognitive deterioration (Addenbrooke's Cognitive Examination ACE score of \< 80).
* Contra-indications to surgery, anaesthesia, or MRI
* compulsory hospitalization/ care; pregnant or nursing patients

Where it's running

• University Hospital of Grenoble Michallon
  Grenoble, France Recruiting
• Chu Nice - Hopital Pasteur
  Nice, France Recruiting
• APHP La Pitié Salpêtrière
  Paris, France Recruiting
• Ghu Sainte Anne
  Paris, France Recruiting
• Universitätsklinikum Köln (AöR)
  Cologne, Germany Recruiting
• Djurfeldt
  Stockholm, Sweden Recruiting

Study contacts

• Principal investigator: Mircea Polosan, MD PhD — University Hospital, Grenoble
• Study coordinator: Sandra David-tchouda, MD
• Email: SDavidTchouda@chugrenoble.fr
• Phone: +33476767186

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.