DeBraStE: Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Late-treated PD patients Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease > 10 years |
Device: Deep Brain Stimulation
Deep Brain Stimulation of STN in Parkinsonian patients
Other Names:
|
| Early-treated PD patients Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease <7 years |
Device: Deep Brain Stimulation
Deep Brain Stimulation of STN in Parkinsonian patients
Other Names:
|
Outcome Measures
Primary Outcome Measures
- percentage of improvement in motor aspects [after 12 months of stimulation]
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.
Secondary Outcome Measures
- Neuropsychological aspects [after 3 and12 months of stimulation]
Evaluation of changes in the global cognitive efficiency short tem memory attention logical/executive functions abstract reasoning verbal fluency tasks visuospatial and visuoconstructional abilities
- Psychiatrical aspects [after 3 and12 months of stimulation]
Evaluation of changes in depression assessed by the Beck Depression Inventory
- Quality of Life [after 3 and12 months of stimulation]
Evaluation of changes in quality of life assessed by PDQ39
- Medication intake [after 3 and12 months of stimulation]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
suffering from PD of > 10 years and with LTS (long term L-dopa syndrome), or with a duration of PD of 5 years
-
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:
-
Any form of familiar PD
-
Presence of neoplasia
-
Presence of HIV
-
Presence of severe metabolic diseases
-
Severe cardiac/respiratory/renal or hepatic diseases
-
Ongoing treatment with immunodepressive/ immunomodulate drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliera Ospedali Riuniti di Bergamo | Bergamo | Lombardy | Italy | 24128 |
Sponsors and Collaborators
- A.O. Ospedale Papa Giovanni XXIII
- Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo
Investigators
- Principal Investigator: Bruno Ferraro, MD, Azienda Ospedaliera Ospedali Riuniti di Bergamo
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- Lang AE, Lozano AM. Parkinson's disease. First of two parts. N Engl J Med. 1998 Oct 8;339(15):1044-53. Review.
- 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.
- 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.
- Schrag A, Quinn N. Dyskinesias and motor fluctuations in Parkinson's disease. A community-based study. Brain. 2000 Nov;123 ( Pt 11):2297-305.
- 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.
- BG200911