Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 1:20 AM
Study NCT ID:
NCT07176494
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Revision of Deep Brain Stimulator in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'up to 24 hours', 'description': 'Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest and when coughing. Pain assessment will be made at 0, 1, 6, 12, 18, and 24 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'postoperative 24th hour', 'description': 'Patient satisfaction will be evaluated using a Likert scale.Evaluation will be made using a 5-point Likert scale (1= I am not satisfied at all - 5= I am very satisfied).'}, {'measure': 'Need for additional analgesics', 'timeFrame': 'postoperative 24th hour', 'description': 'Additional analgesic need will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pectoserratus block', 'Interpektoral block', 'Deep brain stimulation', 'Awake surgery'], 'conditions': ['Pain Management', 'Regional Anesthesia', 'Deep Brain Stimulation', 'Parkinsons Disease']}, 'descriptionModule': {'briefSummary': "Parkinson's disease is a chronic and progressive neurodegenerative disease that affects the central nervous system, particularly impairing movement control. It is associated with the loss of dopamine-producing cells in the brain and typically occurs in middle age and beyond. Deep brain stimulation (DBS) is considered when symptoms of Parkinson's disease, such as tremors, slowed movements, and muscle rigidity, are not adequately controlled with medications. Selected patients with severe symptoms that do not respond to medical treatment are generally considered for this treatment.\n\nBattery revision surgeries can be performed under general anesthesia or regional anesthesia. Patients undergoing general anesthesia should be cautious about the potential complications of general anesthesia, while those undergoing regional anesthesia should be cautious about the local anesthetic systemic toxicity. Because each method has its own advantages, the choice of anesthesia may vary.\n\nThis study aimed to compare postoperative analgesic efficacy and patient satisfaction in patients who underwent surgery under general anesthesia or sedation-assisted battery replacement under regional anesthesia. Both anesthesia methods are routinely used in Parkinson's disease patients undergoing battery replacement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those aged 40-85\n* Those with an ASA score of I-II-III\n* Those with a body mass index (BMI) between 18-30\n\nExclusion Criteria:\n\n* Those under 40 and over 85\n* Those with an ASA score of IV or higher\n* Those with a BMI of under 18 and over 30'}, 'identificationModule': {'nctId': 'NCT07176494', 'briefTitle': "Revision of Deep Brain Stimulator in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': "Revision of Deep Brain Stimulator in Patients With Parkinson's Disease: A Comparison of Perioperative Characteristics of Regional and General Anesthesia", 'orgStudyIdInfo': {'id': 'AnkaraEtlik1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients who underwent surgery under general anesthesia', 'description': 'These patients will be operated on under general anesthesia. During the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia.', 'interventionNames': ['Procedure: Patients who underwent surgery under general anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients who underwent surgery under regional anesthesia', 'description': 'These patients will undergo surgery under regional anesthesia. Interpectoral and pectoserratus plane blocks will be applied to these patients. In the block group, bupivacaine and lidocaine are injected using an ultrasound-guided in-plane technique, between the 3rd and 4th ribs, into the interpectoral plane, and into the pectoserratus plane.\n\n25 cc (15 cc 0.5% bupivacaine + 5 cc 2% lidocaine + 5 cc isotonic) local anesthetic solution is prepared. 10 cc of the medication is administered into the interpectoral plane, and 15 cc into the pectoserratus plane.\n\nDuring the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia.', 'interventionNames': ['Procedure: Patients who underwent surgery under regional anesthesia']}], 'interventions': [{'name': 'Patients who underwent surgery under general anesthesia', 'type': 'PROCEDURE', 'description': 'Patients undergoing surgery under general anesthesia will undergo general anesthesia induction. During the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia.', 'armGroupLabels': ['Patients who underwent surgery under general anesthesia']}, {'name': 'Patients who underwent surgery under regional anesthesia', 'type': 'PROCEDURE', 'description': '25 cc (15 cc 0.5% bupivacaine + 5 cc 2% lidocaine + 5 cc isotonic) local anesthetic solution is prepared. 10 cc of the medication is administered into the interpectoral plane, and 15 cc into the pectoserratus plane.\n\nDuring the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia.', 'armGroupLabels': ['Patients who underwent surgery under regional anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'state': 'Yenimahalle\\Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'İbrahim MD Topcu', 'role': 'CONTACT', 'email': 'ibrahimtpc78@gmail.com', 'phone': '05437860316'}, {'name': 'Musa Assoc.Prof Zengin', 'role': 'CONTACT', 'email': 'musazengin@gmail.com', 'phone': '00905307716235'}], 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'İbrahim MD Topcu, MD', 'role': 'CONTACT', 'email': 'ibrahimtpc78@gmail.com', 'phone': '05437860316'}, {'name': 'Musa MD Zengin', 'role': 'CONTACT', 'email': 'musazengin@gmail.com', 'phone': '+905307716235'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'İbrahim Topcu', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}