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Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537795
Recruitment Status : Unknown
Verified August 2015 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : September 2, 2015
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date August 21, 2015
First Posted Date September 2, 2015
Last Update Posted Date January 27, 2016
Study Start Date August 2015
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2015)
Semi-structured Interview [ Time Frame: up to 180 months after surgery ]
A semi-structured interview of patients and one of their family members will be conducted. Patients and family members will be interviewed separately. The interview will consist of several open ended questions around several themes. The interviews for patients and family members will have their own focus. Patient interviews will focus on living with OCD, living with PNS and the decision making process leading to the PNS procedure. Family member interviews will focus on their own experience in their interaction with OCD patients both before and after PNS
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02537795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences
Official Title Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences
Brief Summary In this study the investigators will use semi-structured interviews to qualitatively analyse patient and family member experiences with either deep brain stimulation or other forms of psychiatric neurosurgery.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population In the University Hospital of Leuven, more than thirty patients suffering from severe OCD have been treated with DBS. The investigators will ask patients who are currently being treated with DBS whether they are willing to participate in this study. The investigators will also ask whether one of their family members might participate, preferentially their partner or another close family member. The aim is to include at least ten patients and their family members. OCD patients, who have been treated with anterior capsulotomy, and their family members will also be asked for participation in this study. The aim is to also include ten patients and family members in this group.
Condition Obsessive-Compulsive Disorder
Intervention
  • Device: deep brain stimulation
    Electrical stimulation of the anterior limb of the internal capsule or bed nucleus of the stria terminalis
  • Procedure: anterior capsulotomy
Study Groups/Cohorts
  • Deep Brain Stimulation Patients
    Patients who have previously been treated with a deep brain stimulation procedure for obsessive compulsive disorder will be included in this group
    Intervention: Device: deep brain stimulation
  • Deep Brain Stimulation Family Members
    Family members of patients who have previously been treated with a deep brain stimulation procedure for obsessive compulsive disorder will be included in this group
  • Anterior Capsulotomy Patients
    Patients who have previously been treated with an anterior capsulotomy procedure for obsessive compulsive disorder will be included in this group
    Intervention: Procedure: anterior capsulotomy
  • Anterior Capsulotomy Family Members
    Family members of patients who have previously been treated with an anterior capsulotomy procedure for obsessive compulsive disorder will be included in this group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 1, 2015)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • (family member of) patient who has previously been treated with deep brain stimulation or anterior capsulotomy

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02537795
Other Study ID Numbers s58187
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor Universitaire Ziekenhuizen Leuven
Collaborators Not Provided
Investigators
Principal Investigator: Chris Bervoets, MD, PhD UPC KU Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date August 2015