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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02537795
Other study ID # s58187
Secondary ID
Status Recruiting
Phase N/A
First received August 21, 2015
Last updated January 26, 2016
Start date August 2015
Est. completion date April 2016

Study information

Verified date August 2015
Source Universitaire Ziekenhuizen Leuven
Contact Simon Raymaekers, MD
Phone 003216342690
Email simon.raymaekers@uzleuven.be
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


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


Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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