Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-04-14 @ 12:49 PM
Study NCT ID:
NCT01274832
Status:
UNKNOWN
Last Update Posted:
2011-01-14
First Post:
2011-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, '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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-13', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2011-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of improvement in motor aspects', 'timeFrame': 'after 12 months of stimulation', 'description': 'The primary objective of the study is calculates as:\n\n(UPDRS III 12 months - UPDRS III baseline)/UPDRS III baseline\n\nwhere UPDRS III 12 months means the score of this test in "medication off , stimulation on" condition at 12 months after implant, while UPDRS III baseline means the score of this test in "medication off " condition.'}], 'secondaryOutcomes': [{'measure': 'Neuropsychological aspects', 'timeFrame': 'after 3 and12 months of stimulation', 'description': 'Evaluation of changes in the\n\n* global cognitive efficiency\n* short tem memory\n* attention\n* logical/executive functions\n* abstract reasoning\n* verbal fluency tasks\n* visuospatial and visuoconstructional abilities'}, {'measure': 'Psychiatrical aspects', 'timeFrame': 'after 3 and12 months of stimulation', 'description': 'Evaluation of changes in depression assessed by the Beck Depression Inventory'}, {'measure': 'Quality of Life', 'timeFrame': 'after 3 and12 months of stimulation', 'description': 'Evaluation of changes in quality of life assessed by PDQ39'}, {'measure': 'Medication intake', 'timeFrame': 'after 3 and12 months of stimulation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson', 'DBS of STN', 'PD', 'Deep Brain stimulation of STN', 'Early treatment'], 'conditions': ["Parkinson's Disease", 'DBS', 'Deep Brain Stimulation', 'STN']}, 'referencesModule': {'references': [{'pmid': '9761807', 'type': 'BACKGROUND', 'citation': "Lang AE, Lozano AM. Parkinson's disease. First of two parts. N Engl J Med. 1998 Oct 8;339(15):1044-53. doi: 10.1056/NEJM199810083391506. No abstract available."}, {'pmid': '11050029', 'type': 'BACKGROUND', 'citation': "Schrag A, Quinn N. Dyskinesias and motor fluctuations in Parkinson's disease. A community-based study. Brain. 2000 Nov;123 ( Pt 11):2297-305. doi: 10.1093/brain/123.11.2297."}, {'pmid': '9748038', 'type': 'BACKGROUND', 'citation': "Kumar R, Lozano AM, Kim YJ, Hutchison WD, Sime E, Halket E, Lang AE. Double-blind evaluation of subthalamic nucleus deep brain stimulation in advanced Parkinson's disease. Neurology. 1998 Sep;51(3):850-5. doi: 10.1212/wnl.51.3.850."}, {'pmid': '10408541', 'type': 'BACKGROUND', 'citation': "Moro E, Scerrati M, Romito LM, Roselli R, Tonali P, Albanese A. Chronic subthalamic nucleus stimulation reduces medication requirements in Parkinson's disease. Neurology. 1999 Jul 13;53(1):85-90. doi: 10.1212/wnl.53.1.85."}, {'pmid': '11839838', 'type': 'BACKGROUND', 'citation': "Vingerhoets FJ, Villemure JG, Temperli P, Pollo C, Pralong E, Ghika J. Subthalamic DBS replaces levodopa in Parkinson's disease: two-year follow-up. Neurology. 2002 Feb 12;58(3):396-401. doi: 10.1212/wnl.58.3.396."}, {'pmid': '11575287', 'type': 'BACKGROUND', 'citation': "Deep-Brain Stimulation for Parkinson's Disease Study Group; Obeso JA, Olanow CW, Rodriguez-Oroz MC, Krack P, Kumar R, Lang AE. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med. 2001 Sep 27;345(13):956-63. doi: 10.1056/NEJMoa000827."}, {'pmid': '10768618', 'type': 'BACKGROUND', 'citation': 'Houeto JL, Damier P, Bejjani PB, Staedler C, Bonnet AM, Arnulf I, Pidoux B, Dormont D, Cornu P, Agid Y. Subthalamic stimulation in Parkinson disease: a multidisciplinary approach. Arch Neurol. 2000 Apr;57(4):461-5. doi: 10.1001/archneur.57.4.461.'}, {'pmid': '12438494', 'type': 'BACKGROUND', 'citation': "Mesnage V, Houeto JL, Welter ML, Agid Y, Pidoux B, Dormont D, Cornu P. Parkinson's disease: neurosurgery at an earlier stage? J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):778-9. doi: 10.1136/jnnp.73.6.778. No abstract available."}, {'pmid': '8954307', 'type': 'BACKGROUND', 'citation': 'Carlesimo GA, Caltagirone C, Gainotti G. The Mental Deterioration Battery: normative data, diagnostic reliability and qualitative analyses of cognitive impairment. The Group for the Standardization of the Mental Deterioration Battery. Eur Neurol. 1996;36(6):378-84. doi: 10.1159/000117297.'}, {'pmid': '15097290', 'type': 'RESULT', 'citation': "Volkmann J. Deep brain stimulation for the treatment of Parkinson's disease. J Clin Neurophysiol. 2004 Jan-Feb;21(1):6-17. doi: 10.1097/00004691-200401000-00003."}, {'pmid': '16107348', 'type': 'RESULT', 'citation': 'Diamond A, Jankovic J. The effect of deep brain stimulation on quality of life in movement disorders. J Neurol Neurosurg Psychiatry. 2005 Sep;76(9):1188-93. doi: 10.1136/jnnp.2005.065334.'}, {'pmid': '17151341', 'type': 'RESULT', 'citation': 'Schupbach WM, Maltete D, Houeto JL, du Montcel ST, Mallet L, Welter ML, Gargiulo M, Behar C, Bonnet AM, Czernecki V, Pidoux B, Navarro S, Dormont D, Cornu P, Agid Y. Neurosurgery at an earlier stage of Parkinson disease: a randomized, controlled trial. Neurology. 2007 Jan 23;68(4):267-71. doi: 10.1212/01.wnl.0000250253.03919.fb. Epub 2006 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the impact of DBS not only no motor outcomes, but also on neuropsychological and psychiatric aspects and on quality of life in young patients with a short history of disease.', 'detailedDescription': 'Bilateral STN DBS is a powerful treatment for advanced Parkinson disease with Levodopa induced motor complications. The beneficial effects of STN stimulation on motor disability and quality of life have been proved. However, the mean delay before neurosurgery is currently 14 years after diagnosis, when medical treatment no longer controls PD symptoms and quality of life is already severely impaired.\n\nAim of this study is to prospectively assess the effects of bilateral STN stimulation on motor signs, psychological and psychiatric aspects and quality of life in a group of 20 patients with PD who underwent surgery after 5 years from the onset of the disease. These results will be compared with those of a group of 20 patients with a PD history from more than 10 years.\n\nThe two groups of patients will be evaluated at baseline and after 3 and 12 months from DBS implant; at each visit neurological and motor examinations were assessed and dedicated neuropsychological and psychiatric tests will be performed.\n\nNeurosurgery may be considered superior to medical treatment alone even in mild to moderate PD of 10 years duration, rather than a last resort in very advanced stages of the disease. Thanks to this study we could compare motor outcomes and cognitive aspects between DBS patients with a short and with long history of disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective clinical study will enroll 40 patients affected by PD. Patients enrolled will be divided into two groups based on the duration of disease. The first group will be composed by patients with PD duration of 5, while the second group will be composed by patients with a duration of disease longer than 10 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suffering from PD of \\> 10 years and with LTS (long term L-dopa syndrome), or with a duration of PD of 5 years\n* age\\< 70 years\n* normal brain MRI\n* absence of dementia (Mini Mental State Examination ≥ 24)\n* absence of severe psychiatric diseases\n* Signed informed consent form\n* Absence of allergy to metal\n* Italian native speaker\n* Absence of communicative or perceptive deficits\n\nExclusion Criteria:\n\n* Any form of familiar PD\n* Presence of neoplasia\n* Presence of HIV\n* Presence of severe metabolic diseases\n* Severe cardiac/respiratory/renal or hepatic diseases\n* Ongoing treatment with immunodepressive/ immunomodulate drugs'}, 'identificationModule': {'nctId': 'NCT01274832', 'acronym': 'DeBraStE', 'briefTitle': 'Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient', 'organization': {'class': 'OTHER', 'fullName': 'A.O. Ospedale Papa Giovanni XXIII'}, 'officialTitle': 'Prospective Study to Compare the Impact on Motor, Neuropsychological, Psychiatric Outcomes and Quality of Life of STN-DBS Between Early Treated and Late-treated PD Patients.', 'orgStudyIdInfo': {'id': 'BG200911'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Late-treated PD patients', 'description': 'Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease \\> 10 years', 'interventionNames': ['Device: Deep Brain Stimulation']}, {'label': 'Early-treated PD patients', 'description': 'Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease \\<7 years', 'interventionNames': ['Device: Deep Brain Stimulation']}], 'interventions': [{'name': 'Deep Brain Stimulation', 'type': 'DEVICE', 'otherNames': ['DBS'], 'description': 'Deep Brain Stimulation of STN in Parkinsonian patients', 'armGroupLabels': ['Early-treated PD patients', 'Late-treated PD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24128', 'city': 'Bergamo', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}], 'centralContacts': [{'name': 'Bruno Ferraro, MD', 'role': 'CONTACT', 'email': 'alkmane@yahoo.it', 'phone': '0039035269411'}, {'name': 'Dario Alimonti, MD', 'role': 'CONTACT', 'email': 'alimonti@hotmail.com', 'phone': '0039035269414'}], 'overallOfficials': [{'name': 'Bruno Ferraro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera Ospedali Riuniti di Bergamo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O. Ospedale Papa Giovanni XXIII', 'class': 'OTHER'}, 'collaborators': [{'name': 'Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Bruno Ferraro', 'oldOrganization': 'Azienda Ospedaliera Ospedali Riuniti di Bergamo'}}}}