White Matter Pathology in Parkinson's Disease (PD) | NCT01039831

Studies
White Matter Pathology in Parkinson's Disease (PD)

NCT01039831

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Dec 25, 2009Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

White Matter Lesions
Postural Instability Gait Disorders

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Not provided

Completion Date

Jan 2012Estimated

First Submitted Date

Dec 23, 2009

First Submission Date that Met QC Criteria

Dec 24, 2009

First Posted Date

Dec 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2009

Last Update Posted Date

Dec 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Label	Type	Description	Intervention Names
Patients with Parkinson's Disease		Consecutive patient sampling

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nir Giladi, MD	Contact	+972-3-6974790		ngiladi@tasmc.healht.gov.il
Talia Herman, MSc	Contact	+972-3-6974958		talit@tasmc.health.gov.il

Overall Officials

Name	Affiliation	Role
Nir Giladi, MD	Director of the Neurology Department, Tel Aviv Sourasky Medical Center, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center		Tel Aviv		64239	Israel

Condition Browse Module

MeSH Terms

ID	Term
D014202	Tremor

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided