White Matter Pathology in Parkinson's Disease (PD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01039831
First received: December 23, 2009
Last updated: December 24, 2009
Last verified: December 2009
  Purpose

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
White Matter Lesions
Postural Instability Gait Disorders

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Groups/Cohorts
Patients with Parkinson's Disease
Consecutive patient sampling

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039831

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

Locations
Israel
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
Investigators
Principal Investigator: Nir Giladi, MD Director of the Neurology Department, Tel Aviv Sourasky Medical Center, Israel
  More Information

No publications provided

Responsible Party: Nir Giladi MD, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01039831     History of Changes
Other Study ID Numbers: 0595-09-TLV
Study First Received: December 23, 2009
Last Updated: December 24, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
PIGD
tremor
falls
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

ClinicalTrials.gov processed this record on August 28, 2014