Deep brain stimulation
Devicesurgical procedure
Other names: DBS
Recruiting
NCT Number: NCT02844049
European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–69 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
CHU Henri Mondor, Créteil, France
Loading trial locations.
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
Time frame: 1 year
QOL assessment : scores at SF36
Secondary outcomes
-
Psychiatric assessment n°1
Time frame: 1 year
clinical profile defined by score at YBOCS -Yale Brown Obsessive Compulsive Scale
-
Psychiatric assessment n°2
Time frame: 1 year
clinical profile defined by score at DYBOCS- Dimensional Yale Brown Obsessive Compulsive Scale
-
Psychiatric assessment n°3
Time frame: 1 year
clinical profile defined by score at YMRS (Young Mania Rating Scale)
-
Psychiatric assessment n°4
Time frame: 1 year
clinical profile defined by score at HAMA (Hamilton Rating Scale for Anxiety)
-
Psychiatric assessment n°5
Time frame: 1 year
clinical profile defined by score at STAI (State-Trait Anxiety Inventory)
-
Psychiatric assessment n°6
Time frame: 1 year
clinical profile defined by score at UPPS-P Impulsive Behavior Scale
-
Psychiatric assessment n°7
Time frame: 1 year
clinical profile defined by score at Clinical Global Impression (Severity of OCD)
-
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°1
Time frame: 1 year
Functioning scores : GAF (Global assessment functioning scale)
-
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°2
Time frame: 1 year
Functioning scores : WHODAS 2.0
-
side effects
Time frame: 1 year
Number of patients with side effects related to medical treatment, surgery and to stimulation
-
Psychiatric markers n°1
Time frame: 1 year
scores at Big Five Inventory
-
Psychiatric markers n°2
Time frame: 1 year
scores at BABS (BROWN ASSESSMENT OF BELIEFS SCALE)
-
Neurological markers n°3
Time frame: 1 year
score at UPDRS (Unified Parkinson's Disease Rating Scale)
-
Neuropsychological markers n°4
Time frame: 1 year
Score at OBQ-44 (Obsessive Beliefs Questionnaire)
-
Neuropsychological markers n°5
Time frame: 1 year
Score at MCQ (Metacognitions questionnaires)
-
Neuropsychological markers n°6
Time frame: 1 year
Score at URICA (University Rhode Island Change Assessment Scale)
-
Neuropsychological markers
Time frame: 1 year
Score at Addenbrooke Cognitive Examination (ACE) battery
-
Per-op electrophysiological mapping of the STN activity n°1
Time frame: 1 year
electrophysiological parameters at rest and during OCD provocative tests
-
Per-op electrophysiological mapping of the STN activity n°2
Time frame: 1 year
electrophysiological parameters at rest and during OCD uncertainty test
-
Per-op electrophysiological mapping of the STN activity n°3
Time frame: 1 year
electrophysiological parameters at rest and during OCD emotional test
-
Per-op electrophysiological mapping of the STN activity n°4
Time frame: 1 year
electrophysiological parameters at rest and during OCD cognitive and motor test
-
Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD
Time frame: 1 year
Measure of suicidal risk with MADRS scale
Study contacts
Contact information is provided by the study sponsor or research team.
Sandra David-tchouda, MD
CONTACT
Sandrine Massicot, Master
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Grenoble
Other
Registry information
Official study title
European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment
Acronym: EQOLOC
Important dates
- Study start
- 2016
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Jul 26, 2016
- Registry last updated
- Nov 29, 2023
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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