- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02377375
Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD): Improving Targeting Precision
January 26, 2016 updated by: Universitaire Ziekenhuizen KU Leuven
Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) in the Bed Nucleus of the Stria Terminalis (BNST): Improving Targeting Precision
When comparing targeting precision between DBS in parkinsonian patients and OCD patients, an unexpected deviation from the planned targets was discovered in OCD patients (Nuttin et al., 2013).
The objective of this trial is to investigate whether the use of a micro-electrode assisted technique improves targeting precision in DBS at the BNST.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- 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
- Name: Bart Nuttin, MD, PHD
- Phone Number: 003216340859
- Email: bart.nuttin@kuleuven.be
Study Contact Backup
- Name: Simon Raymaekers, MD
- Phone Number: 003216342690
- Email: simon.raymaekers@uzleuven.be
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- Recruiting
- UZ Leuven
-
-
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
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
- Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
- Failure of documented trial of cognitive and behavioural therapy
- Duration of illness: min. 5 year
- Y-BOCS (Yale-Brown Obsessive Compulsive Scale) at least 30/40.
- Age: 20-65 year
Exclusion Criteria:
- DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
- DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
- Present or past history of psychotic symptoms.
- Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
- Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
- Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Micro-assisted
In each patient, one electrode will be implanted using the standard technique and one electrode will be implanted using the micro-electrode assisted technique.
The side is randomized.
|
Medtronic DBS lead 3391-28cm Medtronic electrode array microrecording 22670
|
Active Comparator: Standard
In each patient, one electrode will be implanted using the standard technique and one electrode will be implanted using the micro-electrode assisted technique.
The side is randomized.
|
Medtronic DBS lead 3391-28cm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Millimeter difference in position between planned and actual target
Time Frame: 4 weeks after surgery
|
4 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bart Nuttin, MD, PHD, UZ Leuven
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.
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
January 1, 2015
Primary Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
January 27, 2015
First Submitted That Met QC Criteria
February 25, 2015
First Posted (Estimate)
March 3, 2015
Study Record Updates
Last Update Posted (Estimate)
January 27, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S57471
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obsessive-Compulsive Disorder
-
Anne Katrine PagsbergCopenhagen Trial Unit, Center for Clinical Intervention Research; Danish Research...Active, not recruitingObsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceDenmark
-
Baylor College of MedicineRecruitingObsessive-Compulsive Disorder | Cognitive Behavioral Therapy | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
-
Chaim HuijserLevvelRecruitingObsessive-Compulsive Disorder | Anxiety Disorders and Symptoms | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceNetherlands
-
Stanford UniversityCompletedObsessive Compulsive DisorderUnited States
-
NYU Langone HealthCompletedObsessive Compulsive DisorderUnited States
-
Massachusetts General HospitalActive, not recruitingObsessive Compulsive DisorderUnited States
-
Boston University Charles River CampusCompletedObsessive Compulsive DisorderUnited States
-
Butler HospitalNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive DisorderUnited States
-
Karolinska InstitutetCompletedObsessive Compulsive DisorderSweden
-
Roseli ShavittCompleted
Clinical Trials on Micro-assisted technique
-
Royal Fertility Center, EgyptHawaa Fertility CenterCompletedInfertility | Assisted Reproductive TechnologyEgypt
-
Hama UniversityRecruitingCrowding of Anterior Mandibular TeethSyrian Arab Republic
-
Children's Hospital of PhiladelphiaActive, not recruiting
-
Algemeen Ziekenhuis Maria MiddelaresCompleted
-
Seoul National University HospitalCompletedLabor AnalgesiaKorea, Republic of
-
Riphah International UniversityCompletedSpinal Cord InjuriesPakistan
-
Aljazeera HospitalAdam International HospitalCompleted
-
Antalya Training and Research HospitalCompletedComparison of Different Methods of Nasogastric Tube Insertion in Anesthetized and Intubated PatientsDisorder of AbdomenTurkey
-
William Beaumont HospitalsStryker OrthopaedicsCompletedIntertrochanteric Femur FracturesUnited States
-
Bozok UniversityCompletedAnxiety | Simulation Training | Clinical Decision-making | Nursing StudentsTurkey