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White Matter Pathology in Parkinson's Disease (PD)

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01039831
Collaborator
(none)
120
Enrollment
1
Location
24
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The relationship between WM lesions (WM) and Postural Instability Gait Disorders (PIGD-PD)in Parkinson's disease patients is largely unknown. We hypothesize that sub-clinical WM pathology may be a major contributing factor to PIGD-PD. We will compare two groups of patients with Parkinson's disease (PD): those with PIGD and patients with dominant tremor (n=120)to assess the role of brain WM changes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To compare brain WM burden using MRI in PD patients with and without PIGD. Diffusion tensor imaging (DTI) analysis techniques will be applied.We will quantify PIGD-related symptoms including cognitive function, balance and gait and their associations with MRI findings.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Official Title:
    The Role of White Matter Pathology in the Development of the Postural Instability and Gait Disturbance (PIGD) Type of Parkinson's Disease (PD)
    Study Start Date :
    Jan 1, 2010
    Anticipated Study Completion Date :
    Jan 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with Parkinson's Disease

    Consecutive patient sampling

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      50 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      1. Diagnosis of idiopathic PD, as defined by the UK Brain Bank criteria

      2. Age between 50 and 80 years

      3. Hoehn and Yahr stage II-III

      4. On anti-parkinsonian medications

      5. Mini-Mental State Exam score ≥ 25

      Exclusion Criteria:

      1. Brain surgery in the past including implanted Deep Brain Stimulation

      2. Clinically significant co-morbidities likely to affect gait e.g., acute illness, significant rheumatic, orthopedic disease, dementia, or major depression

      3. Unable to walk independently

      4. Inability to comply with the protocol

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239

      Sponsors and Collaborators

      • Tel-Aviv Sourasky Medical Center

      Investigators

      • Principal Investigator: Nir Giladi, MD, Director of the Neurology Department, Tel Aviv Sourasky Medical Center, Israel

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01039831
      Other Study ID Numbers:
      • 0595-09-TLV
      First Posted:
      Dec 25, 2009
      Last Update Posted:
      Dec 25, 2009
      Last Verified:
      Dec 1, 2009
      Keywords provided by , ,
      PIGD
      tremor
      falls
      white matter
      Additional relevant MeSH terms:
      Parkinson Disease

      Study Results

      No Results Posted as of Dec 25, 2009