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

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ClinicalTrials.gov Identifier: NCT02844049
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE June 15, 2016
First Posted Date  ICMJE July 26, 2016
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02844049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
Official Title  ICMJE European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE Device: Deep Brain Stimulation
surgical procedure
Other Name: DBS
Study Arms  ICMJE
  • Active Comparator: Deep Brain Stimulation
    DBS surgical procedure scheduled and realized
    Intervention: Device: Deep Brain Stimulation
  • No Intervention: Control group
    medical treatment (psycho- and pharmaco-therapy) will continue to be given and optimized according to the defined BMT strategies and criteria
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sandra David-tchouda, MD +33476767186 SDavidTchouda@chugrenoble.fr
Contact: Sandrine Massicot, Master +33476768860 smassicot@chu-grenoble.fr
Listed Location Countries  ICMJE France,   Germany,   Israel,   Italy,   Sweden,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02844049
Other Study ID Numbers  ICMJE 38RC15.344
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mircea Polosan, MD PhD University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP