White Matter Pathology in Parkinson's Disease (PD)

• Conditions: White Matter Lesions; Postural Instability Gait Disorders

• Registration Number: NCT01039831
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2009-12
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-24
• Last Update Submitted: 2009-12-24
• Study First Posted: 2009-12-25
• Last Update Posted: 2009-12-25
• Study Start: 2010-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel