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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

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: Deep Brain Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Deep Brain Stimulation
DBS surgical procedure scheduled and realized
Device: Deep Brain Stimulation
surgical procedure
Other Name: DBS

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Psychiatric assessment n°1 [ Time Frame: 1 year ]
    clinical profile defined by score at YBOCS -Yale Brown Obsessive Compulsive Scale

  2. Psychiatric assessment n°2 [ Time Frame: 1 year ]
    clinical profile defined by score at DYBOCS- Dimensional Yale Brown Obsessive Compulsive Scale

  3. Psychiatric assessment n°3 [ Time Frame: 1 year ]
    clinical profile defined by score at YMRS (Young Mania Rating Scale)

  4. Psychiatric assessment n°4 [ Time Frame: 1 year ]
    clinical profile defined by score at HAMA (Hamilton Rating Scale for Anxiety)

  5. Psychiatric assessment n°5 [ Time Frame: 1 year ]
    clinical profile defined by score at STAI (State-Trait Anxiety Inventory)

  6. Psychiatric assessment n°6 [ Time Frame: 1 year ]
    clinical profile defined by score at UPPS-P Impulsive Behavior Scale

  7. Psychiatric assessment n°7 [ Time Frame: 1 year ]
    clinical profile defined by score at Clinical Global Impression (Severity of OCD)

  8. 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)

  9. 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

  10. side effects [ Time Frame: 1 year ]
    Number of patients with side effects related to medical treatment, surgery and to stimulation

  11. Psychiatric markers n°1 [ Time Frame: 1 year ]
    scores at Big Five Inventory

  12. Psychiatric markers n°2 [ Time Frame: 1 year ]
    scores at BABS (BROWN ASSESSMENT OF BELIEFS SCALE)

  13. Neurological markers n°3 [ Time Frame: 1 year ]
    score at UPDRS (Unified Parkinson's Disease Rating Scale)

  14. Neuropsychological markers n°4 [ Time Frame: 1 year ]
    Score at OBQ-44 (Obsessive Beliefs Questionnaire)

  15. Neuropsychological markers n°5 [ Time Frame: 1 year ]
    Score at MCQ (Metacognitions questionnaires)

  16. Neuropsychological markers n°6 [ Time Frame: 1 year ]
    Score at URICA (University Rhode Island Change Assessment Scale)

  17. Neuropsychological markers [ Time Frame: 1 year ]
    Score at Addenbrooke Cognitive Examination (ACE) battery

  18. Per-op electrophysiological mapping of the STN activity n°1 [ Time Frame: 1 year ]
    electrophysiological parameters at rest and during OCD provocative tests

  19. Per-op electrophysiological mapping of the STN activity n°2 [ Time Frame: 1 year ]
    electrophysiological parameters at rest and during OCD uncertainty test

  20. Per-op electrophysiological mapping of the STN activity n°3 [ Time Frame: 1 year ]
    electrophysiological parameters at rest and during OCD emotional test

  21. 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

  22. Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD [ Time Frame: 1 year ]
    Measure of suicidal risk with MADRS scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844049


Contacts
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Contact: Sandra David-tchouda, MD +33476767186 SDavidTchouda@chugrenoble.fr
Contact: Sandrine Massicot, Master +33476768860 smassicot@chu-grenoble.fr

Locations
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France
CHU Henri Mondor Recruiting
Creteil, France
Contact: Luc MALLET, MD PhD    33149813052    luc.mallet@upmc.fr   
Sub-Investigator: Philippe DOMENECH, MD         
Principal Investigator: Luc MALLET, MD PhD         
University Hospital of Grenoble Michallon Recruiting
Grenoble, France
Contact: Mircea POLOSAN, MD PhD    0033476765414    MPolosan@chu-grenoble.fr   
Principal Investigator: Mircea Polosan, MD PhD         
Sub-Investigator: Stéphan Chabardès, MD PhD         
Sub-Investigator: Anna Castrioto, MD         
APHP La Pitié Salpêtrière Recruiting
Paris, France
Contact: Bruno Millet, MD PhD    33142162894    b.millet@psl.aphp.fr   
Sub-Investigator: Carine KARACHI, MD         
Principal Investigator: Bruno MILLET, MD PhD         
Germany
Universitätsklinikum Freiburg (i.Br.) Not yet recruiting
Freiburg, Germany
Contact: Volker COENEN, MD         
Sub-Investigator: Peter GOLL, MD         
Principal Investigator: Volker COENEN, MD         
Universitätsklinikum Köln (AöR) Not yet recruiting
Koln, Germany
Contact: Veerle VISSER-VANDEWALLE, MD    +49 221 478-82793    veerle.visser-vandewalle@uk-koeln.de   
Sub-Investigator: Jens KUHN, MD PhD         
Principal Investigator: Veerle VISSER-VANDEWALLE, MD         
Israel
Hadassah Medical Center The Hebrew University Not yet recruiting
Jerusalem, Israel
Contact: Zvi ISRAEL, MD       israelz@hadassah.org.il   
Sub-Investigator: Renana EITAN, MD         
Sub-Investigator: Hagaï BERGMAN, MD         
Principal Investigator: Zvi ISRAEL, MD         
Italy
DISS - Università degli Studi di Milano Not yet recruiting
Milano, Italy
Contact: Orsola GAMBINI, MD    +39 0250323132    orsola.gambini@unimi.it   
Sub-Investigator: Angelo FRANZINI, MD         
Principal Investigator: Orsola GAMBINI, MD         
Sweden
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden
Contact: Gaston SCHECHTMANN, MD PhD    +46 70 403 5999    gaston.schechtmann@karolinska.se   
Sub-Investigator: Diana DJURFELDT, MD         
Principal Investigator: Gaston SCHECHTMANN, MD PhD         
Switzerland
Hôpitaux Universitaires de Genève Not yet recruiting
Geneve, Switzerland
Contact: Paul KRACK, MD PhD       paul.krack@ujf-grenoble.fr   
Sub-Investigator: Shahan MOMJIAN, MD         
Sub-Investigator: Joao FLORES, MD         
Principal Investigator: Paul KRACK, MD PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Mircea Polosan, MD PhD University Hospital, Grenoble

Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02844049     History of Changes
Other Study ID Numbers: 38RC15.344
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
Deep Brain Stimulation
Quality of Life

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders