Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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.

Conditions
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DBS, Parkinson's Disease, Deep Brain Stimulation, STN

Intervention / Treatment
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* Device: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Late-treated PD patients<br>Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease > 10 years | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation of STN in Parkinsonian patients<br>* Other names: DBS;|
| Early-treated PD patients<br>Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease <7 years | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation of STN in Parkinsonian patients<br>* Other names: DBS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological aspects | Evaluation of changes in the global cognitive efficiency short tem memory attention logical/executive functions abstract reasoning verbal fluency tasks visuospatial and visuoconstructional abilities | after 3 and12 months of stimulation | 
| Psychiatrical aspects | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson, DBS of STN, PD, Deep Brain stimulation of STN, Early treatment