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

This study is not yet open for participant recruitment.
Verified October 2008 by Ospedali Riuniti di Bergamo
Sponsor:
Collaborator:
Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo
Information provided by:
Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier:
NCT01274832
First received: January 11, 2011
Last updated: January 13, 2011
Last verified: October 2008
History of Changes
  Purpose

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 Intervention
Parkinson's Disease
DBS
Deep Brain Stimulation
STN
 Device: Deep Brain Stimulation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ospedali Riuniti di Bergamo:

Primary Outcome Measures:
  • percentage of improvement in motor aspects [ Time Frame: after 12 months of stimulation ] [ Designated as safety issue: No ]

    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 [ Time Frame: after 3 and12 months of stimulation ] [ Designated as safety issue: No ]

    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 [ Time Frame: after 3 and12 months of stimulation ] [ Designated as safety issue: No ]
    Evaluation of changes in depression assessed by the Beck Depression Inventory

  • Quality of Life [ Time Frame: after 3 and12 months of stimulation ] [ Designated as safety issue: No ]
    Evaluation of changes in quality of life assessed by PDQ39

  • Medication intake [ Time Frame: after 3 and12 months of stimulation ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: DBS
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 Name: DBS

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274832

Contacts
Contact: Bruno Ferraro, MD 0039035269411 alkmane@yahoo.it
Contact: Dario Alimonti, MD 0039035269414 alimonti@hotmail.com

Locations
Italy
Azienda Ospedaliera Ospedali Riuniti di Bergamo
Bergamo, Lombardy, Italy, 24128
Sponsors and Collaborators
Ospedali Riuniti di Bergamo
Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo
Investigators
Principal Investigator: Bruno Ferraro, MD Azienda Ospedaliera Ospedali Riuniti di Bergamo
  More Information

Publications:

Responsible Party: Bruno Ferraro, Azienda Ospedaliera Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier: NCT01274832     History of Changes
Other Study ID Numbers: BG200911
Study First Received: January 11, 2011
Last Updated: January 13, 2011
Health Authority: Italy: National Bioethics Committee

Keywords provided by Ospedali Riuniti di Bergamo:
Parkinson
DBS of STN
PD
Deep Brain stimulation of STN
Early treatment

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013