White Matter Pathology in Parkinson's Disease (PD)
Recruitment status was Not yet recruiting
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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) |
| 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 |
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:
- Diagnosis of idiopathic PD, as defined by the UK Brain Bank criteria
- Age between 50 and 80 years
- Hoehn and Yahr stage II-III
- On anti-parkinsonian medications
- Mini-Mental State Exam score ≥ 25
Exclusion Criteria:
- Brain surgery in the past including implanted Deep Brain Stimulation
- Clinically significant co-morbidities likely to affect gait e.g., acute illness, significant rheumatic, orthopedic disease, dementia, or major depression
- Unable to walk independently
- Inability to comply with the protocol
Contacts and Locations| Contact: Nir Giladi, MD | +972-3-6974790 | ngiladi@tasmc.healht.gov.il |
| Contact: Talia Herman, MSc | +972-3-6974958 | talit@tasmc.health.gov.il |
| 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 | |
| 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 May 16, 2013