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

July 9, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

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 Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Simon Raymaekers, MD
          • Phone Number: 003216342690

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: deep brain stimulation
Electrical stimulation of the anterior limb of the internal capsule or bed nucleus of the stria terminalis
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 180 months after surgery

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Chris Bervoets, MD, PhD, UPC KU Leuven

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

August 1, 2015

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimated)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s58187

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.

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