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

• Conditions: Parkinson's Disease; DBS; Deep Brain Stimulation; STN
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT01274832
• Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

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.

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 Timeline

• Status Verified: 2008-10
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Last Update Submitted: 2011-01-13
• Last Update Posted: 2011-01-14
• Study Start: 2011-02
• Primary Completion: 2013-04
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Late-treated PD patients	Deep Brain Stimulation	Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease \> 10 years
Early-treated PD patients	Deep Brain Stimulation	Patients affected by Parkinson Disease, implanted with STN DBS and with an history of disease \<7 years

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Azienda Ospedaliera Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Lombardy, Italy