StrokeNCT01632410
The Autonomic Nervous System State and Response to Different Stimuli Among Patients Post Stroke: A Follow-up Study
An observational study of Stroke, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Post hemispheral ischemic stroke cognitively intact.
Who may be able to join
- Post hemispheral ischemic stroke cognitively intact.
Who cannot join
- Subjects with severe visual or hearing impairments, stroke location brain steam.
Trial locations and contacts
1 site in 1 country.
Natan Borshtain, prof. contact
Israel1 site
Tel Aviv Souraski Medical Center Neurology department
Tel Aviv
Nathan Borshtin, Prof., 972-3-6973159
Noa Raphaelybeer, Mrs., 972-52-8898918, raphaelybeer@gmail.com
About this study
Official title: 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.
Read the 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:
- Prior to the examination subjects will be asked to fill the mRS, NIHSS forms.
- 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.
- Conditions
- Stroke
- Keywords
- autonomic nerve system, post stroke, focus of study: to describe the autonomic nerve system function post stroke, autonomic nervous system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month post stroke
Secondary outcomes (2)
6mwt
Endurance will be measured with the 6 minute walk test (6MWT). we will follow up the endurane change.
Measured: 3 month post stroke
Patient's characteristics
- Patient's characteristics questionnaire will include data such as: age, gender, health condition, medication, habits, education, etc.
- mRS and NIHSS questionears
Measured: 3 month post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nathan Borshtin, Prof., Principal investigator, Tel Aviv Suraski medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632410
- Sponsor's protocol ID
- TASMAC-12-NB-0227-12-CTIL
- Status last verified
- Jun 2012
- First submitted
- 20 Jun 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiac Autonomic Nervous System State and Response to Reflective, Motor and Cognitive Stimuli Among Patients Post Stroke: A Follow-up Study
- ClinicalTrials.gov ID
- NCT01632410
- Acronym / sponsor ID
- TASMAC-12-NB-0227-12-CTIL
- Conditions
- Stroke
- Keywords
- autonomic nerve system, post stroke, focus of study: to describe the autonomic nerve system function post stroke, autonomic nervous system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Prior to the examination subjects will be asked to fill the mRS, NIHSS forms.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Post hemispheral ischemic stroke cognitively intact.
Key inclusion criteria (1 listed)
- Post hemispheral ischemic stroke cognitively intact.
Key exclusion criteria (1 listed)
- Subjects with severe visual or hearing impairments, stroke location brain steam.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RMSSD change
Time frame: 3 month post stroke
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
2 secondary outcomes
6mwt
Time frame: 3 month post stroke
Patient's characteristics
Time frame: 3 month post stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natan Borshtain, prof. contact
Nathan Borshtin, Prof. principal investigator
Tel Aviv Suraski medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natan Borshtain, prof. (972-3-6973159), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RMSSD change (time frame: 3 month post stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.