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

European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment

This study is testing if Deep Brain Stimulation can help people with severe OCD who haven't found relief from other treatments feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: University Hospital, Grenoble (Academic / other)
• Locations: 8 sites (Créteil and 7 other locations)
• Trial ID: NCT02844049 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with OCD for over five years who have not responded to multiple standard treatments.

Not a fit: Patients with specific OCD symptoms like hoarding or those with a history of psychosis or severe personality disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the quality of life for patients suffering from treatment-resistant OCD.

How similar studies have performed: Other studies have shown promising results with DBS for OCD, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Créteil and 7 other locations

• CHU Henri Mondor — Créteil, France (Completed)
• 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)
• Hôpitaux Universitaires de Genève — Geneva, Switzerland (Recruiting)

Study contacts

• Principal investigator: Mircea Polosan, MD PhD — University Hospital, Grenoble
• Study coordinator: Sandra David-tchouda, MD

Conditions Obsessive-Compulsive Disorder; Deep Brain Stimulation; Quality of Life