European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS

Study Overview
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Brief Summary
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Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more than 40% of patients are resistant to the standard pharmacological and psychotherapy approaches and about 10% show severe disability and require institutionalization. These resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate neural networks. Although promising, these results need nevertheless to be replicated and confirmed within a larger cohort of patients and considering a different main objective, instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond symptom reduction, health-related quality of life (QoL) represents a more important objective of a treatment, as it includes both the individual's functional status and the individual's subjective perception of the impact of the illness on the patient's life. STN DBS induces significant clinical improvement, which may not be proportional to the QoL gain. Consequently, QoL appears to be a better outcome to target in the coming studies than clinical improvement alone. THe investigators thus propose a prospective study assessing the QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT) at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus BMT alone.

Detailed Description
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The study will focus on an innovative therapeutic strategy (DBS) and on an original objective, quality of life, which is considered to better reflect the impact of a therapeutic strategy. Moreover, the study will help to define the predictive biomarkers /biosignatures of response to STN DBS in OCD.

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

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deep Brain Stimulation<br>DBS surgical procedure scheduled and realized | Device: Deep Brain Stimulation<br>* surgical procedure<br>* Other names: DBS;|
| No Intervention: Control group<br>medical treatment (psycho- and pharmaco-therapy) will continue to be given and optimized according to the defined BMT strategies and criteria | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the impact of DBS+BMT versus BMT alone on a measure of Quality of life in resistant OCD patients at 1-year follow-up | QOL assessment : scores at SF36 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric assessment n°1 | clinical profile defined by score at YBOCS -Yale Brown Obsessive Compulsive Scale | 1 year | 
| Psychiatric assessment n°2 | clinical profile defined by score at DYBOCS- Dimensional Yale Brown Obsessive Compulsive Scale | 1 year | 
| Psychiatric assessment n°3 | clinical profile defined by score at YMRS (Young Mania Rating Scale) | 1 year | 
| Psychiatric assessment n°4 | clinical profile defined by score at HAMA (Hamilton Rating Scale for Anxiety) | 1 year | 
| Psychiatric assessment n°5 | clinical profile defined by score at STAI (State-Trait Anxiety Inventory) | 1 year | 
| Psychiatric assessment n°6 | clinical profile defined by score at UPPS-P Impulsive Behavior Scale | 1 year | 
| Psychiatric assessment n°7 | clinical profile defined by score at Clinical Global Impression (Severity of OCD) | 1 year | 
| Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°1 | Functioning scores : GAF (Global assessment functioning scale) | 1 year | 
| Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°2 | Functioning scores : WHODAS 2.0 | 1 year | 
| side effects | Number of patients with side effects related to medical treatment, surgery and to stimulation | 1 year | 
| Psychiatric markers n°1 | scores at Big Five Inventory | 1 year | 
| Psychiatric markers n°2 | scores at BABS (BROWN ASSESSMENT OF BELIEFS SCALE) | 1 year | 
| Neurological markers n°3 | score at UPDRS (Unified Parkinson's Disease Rating Scale) | 1 year | 
| Neuropsychological markers n°4 | Score at OBQ-44 (Obsessive Beliefs Questionnaire) | 1 year | 
| Neuropsychological markers n°5 | Score at MCQ (Metacognitions questionnaires) | 1 year | 
| Neuropsychological markers n°6 | Score at URICA (University Rhode Island Change Assessment Scale) | 1 year | 
| Neuropsychological markers | Score at Addenbrooke Cognitive Examination (ACE) battery | 1 year | 
| Per-op electrophysiological mapping of the STN activity n°1 | electrophysiological parameters at rest and during OCD provocative tests | 1 year | 
| Per-op electrophysiological mapping of the STN activity n°2 | electrophysiological parameters at rest and during OCD uncertainty test | 1 year | 
| Per-op electrophysiological mapping of the STN activity n°3 | electrophysiological parameters at rest and during OCD emotional test | 1 year | 
| Per-op electrophysiological mapping of the STN activity n°4 | electrophysiological parameters at rest and during OCD cognitive and motor test | 1 year | 
| Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD | Measure of suicidal risk with MADRS scale | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation, Quality of Life