Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT02537795
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2015-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semi-structured Interview', 'timeFrame': 'up to 180 months after surgery', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Deep Brain Stimulation', 'Anterior Capsulotomy'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (family member of) patient who has previously been treated with deep brain stimulation or anterior capsulotomy\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02537795', 'briefTitle': 'Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences', 'orgStudyIdInfo': {'id': 's58187'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Deep Brain Stimulation Patients', 'description': 'Patients who have previously been treated with a deep brain stimulation procedure for obsessive compulsive disorder will be included in this group', 'interventionNames': ['Device: deep brain stimulation']}, {'label': 'Deep Brain Stimulation Family Members', 'description': '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'}, {'label': 'Anterior Capsulotomy Patients', 'description': 'Patients who have previously been treated with an anterior capsulotomy procedure for obsessive compulsive disorder will be included in this group', 'interventionNames': ['Procedure: anterior capsulotomy']}, {'label': 'Anterior Capsulotomy Family Members', 'description': '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': [{'name': 'deep brain stimulation', 'type': 'DEVICE', 'description': 'Electrical stimulation of the anterior limb of the internal capsule or bed nucleus of the stria terminalis', 'armGroupLabels': ['Deep Brain Stimulation Patients']}, {'name': 'anterior capsulotomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Anterior Capsulotomy Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Simon Raymaekers, MD', 'role': 'CONTACT', 'phone': '003216342690'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Simon Raymaekers, MD', 'role': 'CONTACT', 'email': 'simon.raymaekers@uzleuven.be', 'phone': '003216342690'}], 'overallOfficials': [{'name': 'Chris Bervoets, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPC KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}