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

January 13, 2011 updated by: A.O. Ospedale Papa Giovanni XXIII

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Bergamo, Lombardy, Italy, 24128
        • Azienda Ospedaliera Ospedali Riuniti di Bergamo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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:
  • 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 Names:
  • DBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of improvement in motor aspects
Time Frame: 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.
after 12 months of stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological aspects
Time Frame: 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
after 3 and12 months of stimulation
Psychiatrical aspects
Time Frame: after 3 and12 months of stimulation
Evaluation of changes in depression assessed by the Beck Depression Inventory
after 3 and12 months of stimulation
Quality of Life
Time Frame: after 3 and12 months of stimulation
Evaluation of changes in quality of life assessed by PDQ39
after 3 and12 months of stimulation
Medication intake
Time Frame: after 3 and12 months of stimulation
after 3 and12 months of stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Collaborators

Associazione Italiana Parkinsoniani (AIP)- Sezione Bergamo

Investigators

  • Principal Investigator: Bruno Ferraro, MD, Azienda Ospedaliera Ospedali Riuniti di Bergamo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2011

Last Update Submitted That Met QC Criteria

January 13, 2011

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BG200911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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