Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient
NCT ID: NCT01274832
Last Updated: 2011-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2011-02-28
2014-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Late-treated PD patients
Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease \> 10 years
Deep Brain Stimulation
Deep Brain Stimulation of STN in Parkinsonian patients
Early-treated PD patients
Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease \<7 years
Deep Brain Stimulation
Deep Brain Stimulation of STN in Parkinsonian patients
Interventions
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Deep Brain Stimulation
Deep Brain Stimulation of STN in Parkinsonian patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age\< 70 years
* normal brain MRI
* absence of dementia (Mini Mental State Examination ≥ 24)
* absence of severe psychiatric diseases
* Signed informed consent form
* Absence of allergy to metal
* Italian native speaker
* Absence of communicative or perceptive deficits
Exclusion Criteria
* Presence of neoplasia
* Presence of HIV
* Presence of severe metabolic diseases
* Severe cardiac/respiratory/renal or hepatic diseases
* Ongoing treatment with immunodepressive/ immunomodulate drugs
18 Years
70 Years
ALL
No
Sponsors
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Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo
UNKNOWN
A.O. Ospedale Papa Giovanni XXIII
OTHER
Responsible Party
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Azienda Ospedaliera Ospedali Riuniti di Bergamo
Principal Investigators
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Bruno Ferraro, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Ospedali Riuniti di Bergamo
Locations
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Azienda Ospedaliera Ospedali Riuniti di Bergamo
Bergamo, Lombardy, Italy
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BG200911
Identifier Type: -
Identifier Source: org_study_id
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