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Restless Legs Syndrome in Stroke Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Ilana Schlesinger, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01967303
First received: September 15, 2013
Last updated: October 17, 2013
Last verified: October 2013
  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 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967303

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

No publications provided

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
Study First Received: September 15, 2013
Last Updated: October 17, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
Restless legs syndrome
Stroke
Transient ischemic attack
Cerebrovascular risk factors

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

ClinicalTrials.gov processed this record on November 25, 2014