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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01632410
• Other study ID #: TASMAC-12-NB-0227-12-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: June 20, 2012
• Last updated: July 2, 2012
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Natan Borshtain, prof.
• Phone: 972-3-6973159
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Post hemispheral ischemic stroke cognitively intact.

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Israel	Tel Aviv Souraski Medical Center Neurology department	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	6mwt	Endurance will be measured with the 6 minute walk test (6MWT). we will follow up the endurane change.	3 month post stroke	No
Secondary	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	No