NCT02537795

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

9.7 years

First QC Date

August 21, 2015

Last Update Submit

July 9, 2024

Conditions

Obsessive-Compulsive Disorder

Keywords

Deep Brain StimulationAnterior Capsulotomy

Outcome Measures

Primary Outcomes (1)

  • Semi-structured Interview

    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

Study Arms (4)

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

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

Interventions

deep brain stimulationDEVICE

Electrical stimulation of the anterior limb of the internal capsule or bed nucleus of the stria terminalis

Deep Brain Stimulation Patients
anterior capsulotomyPROCEDURE
Anterior Capsulotomy Patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Chris Bervoets, MD, PhD

    UPC KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Raymaekers, MD

CONTACT

003216342690simon.raymaekers@uzleuven.be

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2015

First Posted

September 2, 2015

Study Start

August 1, 2015

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations

BE(1)