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

The Cardiac Autonomic Nervous System State and Response to Reflective, Motor and Cognitive Stimuli Among Patients Post Stroke: A Follow-up Study

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.

Study Overview

• Status: Unknown
• Conditions: Stroke

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel Aviv Souraski Medical Center Neurology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post hemispheral ischemic stroke cognitively intact.

Description

Inclusion Criteria:

• Post hemispheral ischemic stroke cognitively intact.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RMSSD change	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	3 month post stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6mwt	Endurance will be measured with the 6 minute walk test (6MWT). we will follow up the endurane change.	3 month post stroke
Patient's characteristics	a. Patient's characteristics questionnaire will include data such as: age, gender, health condition, medication, habits, education, etc. B. mRS and NIHSS questionears	3 month post stroke

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Nathan Borshtin, Prof., Tel Aviv Suraski medical center

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ANTICIPATED): November 1, 2012
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: July 2, 2012
• First Posted (ESTIMATE): July 3, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 3, 2012
• Last Update Submitted That Met QC Criteria: July 2, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: autonomic nervous system; post stroke; autonomic nerve system; focus of study: to describe the autonomic nerve system function post stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: TASMAC-12-NB-0227-12-CTIL