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

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Stroke

Study type

Observational

Funder types

Other

Identifiers

NCT01632410
TASMAC-12-NB-0227-12-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Post hemispheral ischemic stroke cognitively intact.

Exclusion criteria

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

Trial design

100 participants in 5 patient groups

Study group 1
Description:
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
Description:
Control: Healthy subjects resemble in age and sex
Study -3
Description:
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
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Natan Borshtain, prof.; Noa Raphaely Beer, Mrs.

Data sourced from clinicaltrials.gov

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