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White Matter Pathology in Parkinson's Disease (PD)

NCT ID: NCT01039831

Last Updated: 2009-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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White Matter Lesions Postural Instability Gait Disorders

Keywords

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falls PIGD tremor white matter

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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Patients with Parkinson's Disease

Consecutive patient sampling

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel Aviv Sourasky Medical Center

Principal Investigators

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Nir Giladi, MD

Role: PRINCIPAL_INVESTIGATOR

Director of the Neurology Department, Tel Aviv Sourasky Medical Center, Israel

Locations

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Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Nir Giladi, MD

Role: CONTACT

Phone: +972-3-6974790

Email: [email protected]

Talia Herman, MSc

Role: CONTACT

Phone: +972-3-6974958

Email: [email protected]

Facility Contacts

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Jeffrey Hausdorff, PhD

Role: primary

Talia Herman, MScPT

Role: backup

Other Identifiers

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0595-09-TLV

Identifier Type: -

Identifier Source: org_study_id