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| Name | Class |
|---|---|
| Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo | UNKNOWN |
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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.
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.
Aim 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.
The 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.
Neurosurgery 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Late-treated PD patients | Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease > 10 years |
| |
| Early-treated PD patients | Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease <7 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Deep Brain Stimulation of STN in Parkinsonian patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of improvement in motor aspects | The primary objective of the study is calculates as: (UPDRS III 12 months - UPDRS III baseline)/UPDRS III baseline where 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. | after 12 months of stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological aspects | Evaluation of changes in the
| after 3 and12 months of stimulation |
| Psychiatrical aspects |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Ferraro, MD | Contact | 0039035269411 | alkmane@yahoo.it | |
| Dario Alimonti, MD | Contact | 0039035269414 | alimonti@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Ferraro, MD | Azienda Ospedaliera Ospedali Riuniti di Bergamo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Ospedali Riuniti di Bergamo | Bergamo | Lombardy | 24128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9761807 | Background | 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. | |
| 11050029 | Background | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Evaluation of changes in depression assessed by the Beck Depression Inventory |
| after 3 and12 months of stimulation |
| Quality of Life | Evaluation of changes in quality of life assessed by PDQ39 | after 3 and12 months of stimulation |
| Medication intake | after 3 and12 months of stimulation |
| 9748038 | Background | 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. |
| 10408541 | Background | 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. |
| 11839838 | Background | 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. |
| 11575287 | Background | 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. |
| 10768618 | Background | 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. |
| 12438494 | Background | 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. |
| 8954307 | Background | 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. |
| 15097290 | Result | 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. |
| 16107348 | Result | 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. |
| 17151341 | Result | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |