White Matter Pathology in Parkinson's Disease (PD)

The Role of White Matter Pathology in the Development of the Postural Instability and Gait Disturbance (PIGD) Type of Parkinson's Disease (PD)

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Nir Giladi, MD; Phone Number: +972-3-6974790; Email: ngiladi@tasmc.healht.gov.il
• Study Contact Backup: Name: Talia Herman, MSc; Phone Number: +972-3-6974958; Email: talit@tasmc.health.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
    • Contact: Jeffrey Hausdorff, PhD; Email: jhausdor@tasmc.health.gov.il
    • Contact: Talia Herman, MScPT; Email: talit@tasmc.health.gov.il
    • Sub-Investigator: Talia Herman, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with Parkinson's Disease; Consecutive patient sampling

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Study Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 24, 2009
• First Posted (Estimate): December 25, 2009

Study Record Updates

• Last Update Posted (Estimate): December 25, 2009
• Last Update Submitted That Met QC Criteria: December 24, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: falls; white matter; tremor; PIGD
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 0595-09-TLV