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

November 28, 2023 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Creteil, France
        • Completed
        • CHU Henri Mondor
      • Grenoble, France
        • Recruiting
        • University Hospital of Grenoble Michallon
        • Contact:
        • Principal Investigator:
          • Mircea Polosan, MD PhD
        • Sub-Investigator:
          • Stéphan Chabardès, MD PhD
        • Sub-Investigator:
          • Anna Castrioto, MD
      • Nice, France
        • Recruiting
        • CHU Nice - Hôpital Pasteur
        • Contact:
        • Contact:
        • Principal Investigator:
          • Denys FONTAINE, MD
        • Sub-Investigator:
          • Bruno GIORDANA, MD
      • Paris, France
        • Recruiting
        • APHP La Pitié Salpêtrière
        • Contact:
        • Sub-Investigator:
          • Carine KARACHI, MD
        • Principal Investigator:
          • Bruno MILLET, MD PhD
      • Paris, France
  • Germany
      • Koln, Germany
        • Recruiting
        • Universitätsklinikum Köln (AöR)
        • Contact:
        • Sub-Investigator:
          • Jens KUHN, MD PhD
        • Principal Investigator:
          • Veerle VISSER-VANDEWALLE, MD
  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Djurfeldt
        • Contact:
        • Sub-Investigator:
          • Diana DJURFELDT, MD PhD
        • Principal Investigator:
          • Anders FYTAGORIDIS, MD PhD
  • Switzerland
      • Geneve, Switzerland
        • Recruiting
        • Hopitaux Universitaires de Geneve
        • Contact:
        • Sub-Investigator:
          • Shahan MOMJIAN, MD
        • Principal Investigator:
          • Joao FLORES, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Deep Brain Stimulation
DBS surgical procedure scheduled and realized
Device: Deep Brain Stimulation
surgical procedure
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 1 year
QOL assessment : scores at SF36
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychiatric assessment n°1
Time Frame: 1 year
clinical profile defined by score at YBOCS -Yale Brown Obsessive Compulsive Scale
1 year
Psychiatric assessment n°2
Time Frame: 1 year
clinical profile defined by score at DYBOCS- Dimensional Yale Brown Obsessive Compulsive Scale
1 year
Psychiatric assessment n°3
Time Frame: 1 year
clinical profile defined by score at YMRS (Young Mania Rating Scale)
1 year
Psychiatric assessment n°4
Time Frame: 1 year
clinical profile defined by score at HAMA (Hamilton Rating Scale for Anxiety)
1 year
Psychiatric assessment n°5
Time Frame: 1 year
clinical profile defined by score at STAI (State-Trait Anxiety Inventory)
1 year
Psychiatric assessment n°6
Time Frame: 1 year
clinical profile defined by score at UPPS-P Impulsive Behavior Scale
1 year
Psychiatric assessment n°7
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
Functioning scores : WHODAS 2.0
1 year
side effects
Time Frame: 1 year
Number of patients with side effects related to medical treatment, surgery and to stimulation
1 year
Psychiatric markers n°1
Time Frame: 1 year
scores at Big Five Inventory
1 year
Psychiatric markers n°2
Time Frame: 1 year
scores at BABS (BROWN ASSESSMENT OF BELIEFS SCALE)
1 year
Neurological markers n°3
Time Frame: 1 year
score at UPDRS (Unified Parkinson's Disease Rating Scale)
1 year
Neuropsychological markers n°4
Time Frame: 1 year
Score at OBQ-44 (Obsessive Beliefs Questionnaire)
1 year
Neuropsychological markers n°5
Time Frame: 1 year
Score at MCQ (Metacognitions questionnaires)
1 year
Neuropsychological markers n°6
Time Frame: 1 year
Score at URICA (University Rhode Island Change Assessment Scale)
1 year
Neuropsychological markers
Time Frame: 1 year
Score at Addenbrooke Cognitive Examination (ACE) battery
1 year
Per-op electrophysiological mapping of the STN activity n°1
Time Frame: 1 year
electrophysiological parameters at rest and during OCD provocative tests
1 year
Per-op electrophysiological mapping of the STN activity n°2
Time Frame: 1 year
electrophysiological parameters at rest and during OCD uncertainty test
1 year
Per-op electrophysiological mapping of the STN activity n°3
Time Frame: 1 year
electrophysiological parameters at rest and during OCD emotional test
1 year
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
1 year
Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD
Time Frame: 1 year
Measure of suicidal risk with MADRS scale
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mircea Polosan, MD PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC15.344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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