Clinical trial NCT01274832: Prospective Study to Compare Results of STN-DBS Between Early Treated and Late-treated PD Patient
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
DBS
Deep Brain Stimulation
STN
Keywords: Parkinson
DBS of STN
PD
Deep Brain stimulation of STN
Early treatment
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
Collaborators: name: Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo
First posted: 2011-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility 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

Primary outcomes:
measure: percentage of improvement in motor aspects
timeFrame: after 12 months of stimulation
Secondary outcomes:
measure: Neuropsychological aspects
timeFrame: after 3 and12 months of stimulation
measure: Psychiatrical aspects
timeFrame: after 3 and12 months of stimulation
measure: Quality of Life
timeFrame: after 3 and12 months of stimulation
measure: Medication intake
timeFrame: after 3 and12 months of stimulation
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti di Bergamo
state: Lombardy
Study officials:
affiliation: Azienda Ospedaliera Ospedali Riuniti di Bergamo
name: Bruno Ferraro, MD
role: PRINCIPAL_INVESTIGATOR
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