The Autonomic Nervous System State and Response to Different Stimuli Among Patients Post Stroke: A Follow-up Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01632410
First received: June 20, 2012
Last updated: July 2, 2012
Last verified: June 2012
  Purpose

The study describes the autonomic control system function in subjects post stroke in comparison with healthy subjects.

Aims: To describe the Autonomic hart rate control system function in post stroke subjects in different rehabilitation levels in comparison with healthy subjects.

To examine the reflective reaction of the autonomic control system as reflected in the heart rate variability to stimulations subjects in different rehabilitation levels in comparison with healthy subjects.

To examine the autonomic control system reaction as reflected in the heart rate variability to physical and cognitive action subjects in different rehabilitation levels in comparison with healthy subjects.


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Cardiac Autonomic Nervous System State and Response to Reflective, Motor and Cognitive Stimuli Among Patients Post Stroke: A Follow-up Study

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • RMSSD change [ Time Frame: 3 month post stroke ] [ Designated as safety issue: No ]

    The root mean square successive difference (RMSSD) in heart period series is a time domain measure of heart period variability.

    we will follow up the change in RMSSD at 1st and 3rd month post stroke



Secondary Outcome Measures:
  • 6mwt [ Time Frame: 3 month post stroke ] [ Designated as safety issue: No ]
    Endurance will be measured with the 6 minute walk test (6MWT). we will follow up the endurane change.

  • Patient's characteristics [ Time Frame: 3 month post stroke ] [ Designated as safety issue: No ]

    a. Patient's characteristics questionnaire will include data such as: age, gender, health condition, medication, habits, education, etc.

    B. mRS and NIHSS questionears



Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study group 1

Post hemispheral ischemic stroke cognitively intact. Exclusion: Subjects with severe visual or hearing impairments, stroke location brain steam.

The group will be divided in to 4 goups acording to stroke specific location as demonstrated in MRI.

Control
Control: Healthy subjects resemble in age and sex
Study -3
As explained the subjects will be divided into 4 groups acording to the stroke location. this is in order to evaluat the relationship between location and autonomic responed.
Stydy -2
As explained the subjects will be divided into 4 groups acording to the stroke location. this is in order to evaluat the relationship between location and autonomic responed.
Stydy- 4
As explained the subjects will be divided into 4 groups acording to the stroke location. this is in order to evaluat the relationship between location and autonomic responed.

Detailed Description:

Subjects will be examined 3 times: a week 1 and 3 month post stroke. Control consist similar in description healthy subjects, will be examined once. Each test includes 24 hours Holter surveillance and an examine that include general check that reflects the autonomic reaction to different manipulation.

The examination description:

A. Prior to the examination subjects will be asked to fill the mRS, NIHSS forms.

B. Subjects will receive an examination that includes

  • General neurological examination (strength, deep and superficial sensation, cognitive test and pain level.) C. Holter will be place for 24 hours. And autonomic examination test will be conducted
  • Grip Test: emphases the sympathetic system.
  • Breathing Test: emphases the parasympathetic system. D. Manipulation to examine the two sub systems. Each manipulation lasts1 minute.
  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Post hemispheral ischemic stroke cognitively intact.

Criteria

Inclusion Criteria:

  • Post hemispheral ischemic stroke cognitively intact.

Exclusion Criteria:

  • Subjects with severe visual or hearing impairments, stroke location brain steam.
  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: NCT01632410

Contacts
Contact: Natan Borshtain, prof. 972-3-6973159
Contact: Noa Raphaely Beer, Mrs. 972-52-8898918 raphaelybeer@gmail.com

Locations
Israel
Tel Aviv Souraski Medical Center Neurology department Not yet recruiting
Tel Aviv, Israel
Contact: Nathan Borshtin, Prof.    972-3-6973159      
Contact: Noa Raphaelybeer, Mrs.    972-52-8898918    raphaelybeer@gmail.com   
Principal Investigator: Nathan Borshtin, Prof.         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nathan Borshtin, Prof. Tel Aviv Suraski medical center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01632410     History of Changes
Other Study ID Numbers: TASMAC-12-NB-0227-12-CTIL
Study First Received: June 20, 2012
Last Updated: July 2, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
autonomic nerve system
post stroke
focus of study: to describe the autonomic nerve system function post stroke
autonomic nervous system

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014