White Matter Pathology in Parkinson's Disease (PD)

White Matter Lesions Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01039831
• Other study ID #: 0595-09-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: December 23, 2009
• Last updated: December 24, 2009
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: December 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nir Giladi, MD
• Phone: +972-3-6974790
• Email: ngiladi[@]tasmc.healht.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Parkinson Disease
• Postural Instability Gait Disorders
• White Matter Lesions

Locations

Country	Name	City	State
Israel	Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel,