NCT01039831

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 25, 2009

Status Verified

December 1, 2009

First QC Date

December 23, 2009

Last Update Submit

December 24, 2009

Conditions

White Matter LesionsPostural Instability Gait Disorders

Keywords

PIGDtremorfallswhite matter

Study Arms (1)

Patients with Parkinson's Disease

Consecutive patient sampling

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Tremor

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nir Giladi, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nir Giladi, MD

CONTACT

+972-3-6974790ngiladi@tasmc.healht.gov.il

Talia Herman, MSc

CONTACT

+972-3-6974958talit@tasmc.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 25, 2009

Study Start

January 1, 2010

Study Completion

January 1, 2012

Last Updated

December 25, 2009

Record last verified: 2009-12

Locations

IL(1)