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White Matter Pathology in Parkinson's Disease (PD)

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ClinicalTrials.gov Identifier: NCT01039831
Recruitment Status : Unknown
Verified December 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 25, 2009
Last Update Posted : December 25, 2009
Information provided by:
Tel-Aviv Sourasky Medical Center

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
White Matter Lesions Postural Instability Gait Disorders

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 Type : Observational
Estimated 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 : January 2010
Estimated Study Completion Date : January 2012

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U.S. FDA Resources

Patients with Parkinson's Disease
Consecutive patient sampling

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 120 patients with idiopathic Parkinson's disease (PD) will be studied. Subjects will be divided into two groups: Patients with PIGD and patients with tremor dominant.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039831

Contact: Nir Giladi, MD +972-3-6974790 ngiladi@tasmc.healht.gov.il
Contact: Talia Herman, MSc +972-3-6974958 talit@tasmc.health.gov.il

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Jeffrey Hausdorff, PhD       jhausdor@tasmc.health.gov.il   
Contact: Talia Herman, MScPT       talit@tasmc.health.gov.il   
Sub-Investigator: Talia Herman, MSc         
Sub-Investigator: Jeffrey M Hausdorff, PhD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Nir Giladi, MD Director of the Neurology Department, Tel Aviv Sourasky Medical Center, Israel

Responsible Party: Nir Giladi MD, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01039831     History of Changes
Other Study ID Numbers: 0595-09-TLV
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: December 25, 2009
Last Verified: December 2009

Keywords provided by Tel-Aviv Sourasky Medical Center:
white matter

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