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Restless Legs Syndrome in Stroke Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01967303
First Posted: October 22, 2013
Last Update Posted: October 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Ilana Schlesinger, Rambam Health Care Campus
  Purpose
Our study aimed to examine a possible association between Restless legs syndrome and cerebrovascular disease, by examining patients during hospitalization for acute stroke or transient ischemic attack, in a matched case-control design.

Condition
Restless Legs Syndrome Stroke Transient Ischemic Attack

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Restless Legs Syndrome in Stroke Patients

Resource links provided by NLM:


Further study details as provided by Dr. Ilana Schlesinger, Rambam Health Care Campus:

Primary Outcome Measures:
  • Prevalence of Restless legs syndrome in patients with stroke or Transient ischemic attack vs. prevalence in controls. [ Time Frame: At time of interview ]
    The frequency (prevalence) of restless leg syndrome (RLS) in patients who have suffered stroke or TIA will be compared to that of subjects who have not suffered stroke or TIA (controls). The two groups will be stratified with regard to age and gender. Statistical comparison will be made by univariate analyses and by multivariate logistic regression analyses (which will include cerebrovascular risk factors besides stroke or TIA).


Enrollment: 447
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with stroke or transient ischemic attack
Interview regarding restless legs syndrome
Subjects without stroke or transient ischemic attack
Interview regarding restless legs syndrome

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients hospitalized with stroke or transient ischemic attack.
Criteria

Inclusion Criteria:

  • 18 years old or older
  • Hospitalization for stroke or transient ischemic attack

Exclusion Criteria:

  • 18 years old or younger
  • No stroke or transient ischemic attack
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967303


Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ilana Schlesinger Rambam Health Care Campus, Haifa, Israel
  More Information

Responsible Party: Dr. Ilana Schlesinger, Director, Movement Disorders Center, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01967303     History of Changes
Other Study ID Numbers: 3186
First Submitted: September 15, 2013
First Posted: October 22, 2013
Last Update Posted: October 22, 2013
Last Verified: October 2013

Keywords provided by Dr. Ilana Schlesinger, Rambam Health Care Campus:
Restless legs syndrome
Stroke
Transient ischemic attack
Cerebrovascular risk factors

Additional relevant MeSH terms:
Ischemic Attack, Transient
Brain Ischemia
Syndrome
Stroke
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders