Cerebrovascular AccidentNCT00172289
Measurement of Pulse Wave Velocity in Spinal Cord Injury and Stroke Patients
An observational study of Cerebrovascular Accident and Spinal Cord Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
According to the theory of wave transmission, the speed of wave transmission is dependent on the nature of the transmission medium, which is the vessel wall for pulse wave transmission. Then, the pulse wave velocity is related to the mechanical property of the vessel wall. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident, Spinal Cord Injury
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2004to Dec 2006
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke patients with shoulder pain
- Spinal cord injury patients with complete cervical lesion
Who cannot join
- Peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Wang Tyng-Guey
Taipei
Wang Tyng-Guey, MD, 886-2-23123456 ext. 7588, tgw@ha.mc.ntu.edu.tw
Wang Chung-Li
About this study
According to the theory of wave transmission, the speed of wave transmission is dependent on the nature of the transmission medium, which is the vessel wall for pulse wave transmission. Then, the pulse wave velocity is related to the mechanical property of the vessel wall. The mechanical property of the vessel wall is determined by the texture of the vessel wall and the contraction status of the smooth muscle within the vessel wall. Because the texture of the vessel wall could not be changed in a short duration, the sympathetic nerve activity, which controls the contractibility of the smooth muscle, becomes the only determinant factor of pulse wave velocity. So, pulse wave velocity may reflect the status of sympathetic nerve activity. The purpose of this project is to use the pulse wave velocity to measure the sympathetic activity of stroke and spinal cord patients. The present project plans to measure the pulse wave simultaneously at four limbs by pressure receptors, and use the electrocardiogram as the reference to synchronize the recorded pulse wave at different vessels, using the corrected data to calculate the pulse wave velocity. With the pulse wave velocity of different vessels, we, the investigators at National Taiwan University Hospital, can understand the local sympathetic nerve activity in different diseases and different sites.
The first year, we will set up the equipment for measuring the pulse wave velocity, and then apply it to 20 healthy subjects to adjust the measurement error and ascertain the reproducibility of the machine. The second year, we will apply the measurement to 15 complete cervical cord injury individuals and 15 healthy subjects in different erected angles by a tilting table. This procedure will make us understand the response of sympathetic nerve activity to different postures in normal subjects and cervical cord injury patients. The third year, we will apply the measurement to 30 cerebrovascular accident patients to understand the change of sympathetic nerve activity after having a stroke. By comparing the clinical information, we hope to clear up the relationship between sympathetic nerve activity and pulse wave velocity.
Read the detailed description
There are many diseases related to the dysfunction of sympathetic nerve activities in rehabilitation medicine. Shoulder hand syndrome, a common complication after having a cerebrovascular accident, is believed to combine with hyper-exciting of the sympathetic nerve at the lesion side. Autonomic dysfunction in spinal cord injury patients comes from the vicious cycle of local stimulation of the sympathetic nerve and results in the elevated blood pressure. Myofascial pain syndrome has been reported to have abnormal sympathetic activities in the late stage. Considering the above facts, accurate evaluation of sympathetic nerve activities is an important issue in rehabilitation practice.
Measuring the skin temperature and the status of local sweating are the common methods in evaluating the sympathetic nerve activity. However, many external environment factors would interfere with the result, and the accuracy of the result is questionable. Sympathetic skin reflex is the traditional electrodiagnostic method in measuring the sympathetic nerve activity, but its application is limited by poor reproducibility. Microneurography can measure the sympathetic nerve activity along the distribution of peroneus and bronchial nerves by inserting the needles into the above nerves, but its application is limited because of the invasive nature of the test.
When the heart is contracted, it pumps the blood into the peripheral vessels and transits a pulse wave along the vessel walls. The propagation velocity of the pulse wave is different from that of the blood flow. According to the theory of wave transmission, the speed of wave transmission is dependent on the nature of the transmission medium, which is the vessel wall for pulse wave transmission. Then, the pulse wave velocity is related to the mechanical property of the vessel wall. The mechanical property of the vessel wall is determined by the texture of the vessel wall and the contraction status of the smooth muscle within the vessel wall. Because the texture of the vessel wall could not be changed in a short duration, the sympathetic nerve activity, which controls the contractibility of the smooth muscle, becomes the only determinant factor of pulse wave velocity. So, pulse wave velocity may reflect the status of sympathetic nerve activity.
There were limited reports regarding the pulse wave velocity measurement and lack of reports of clinical application. The present project plans to measure the pulse wave simultaneously at four limbs by pressure receptors, and use the electrocardiogram as the reference to synchronize the recorded pulse wave at different vessels, using the corrected data to calculate the pulse wave velocity. With the pulse wave velocity of different vessels, we can understand the local sympathetic nerve activity in different diseases and different sites.
The first year, we will set up the equipment for measuring the pulse wave velocity, and then apply it to 20 healthy subjects to adjust the measurement error and ascertain the reproducibility of the machine. The second year, we will apply the measurement to 15 complete cervical cord injury individuals and 15 healthy subjects in different erected angles by a tilting table. This procedure will make us understand the response of sympathetic nerve activity to different postures in normal subjects and cervical cord injury patients. The third year, we will apply the measurement to 30 cerebrovascular accident patients to understand the change of sympathetic nerve activity after having a stroke. By comparing the clinical information, we hope to clear up the relationship between sympathetic nerve activity and pulse wave velocity.
The study will use the self-designed pulse wave velocity (PWV) machine to measure the patients with cerebrovascular accident (CVA) and spinal cord injury (SCI). The CVA patients will be divided into two groups with or without shoulder pain. The skin temperature and range of motion will be recorded. We hypothesize that the patients with shoulder pain may have higher sympathetic activity and will have higher speed of PWV. Sixty patients will be included. For SCI patients, we will compare the PWV of the upper extremity and lower extremity. We hypothesize that the cervical cord injury patients will have lower sympathetic tone below the lesion, and have lower speed of PWV when compared to the upper extremity.
Through this study, we will confirm the hypothesis that the PWV is an accurate method to measure the sympathetic activity and understand the change of sympathetic activity in CVA and SCI patients.
- Conditions
- Cerebrovascular Accident, Spinal Cord Injury
- Keywords
- pulse wave velocity, sympathetic nerve activity, spinal cord injury, cerebrovascular accident
- Medical subject headings
- Stroke, Spinal Cord Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wang Tyng-Guey, MD, Study director, National Taiwan University, School of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172289
- Sponsor's protocol ID
- 9261701395
- Status last verified
- Dec 2004
- First submitted
- 12 Sep 2005
- Last updated
- 9 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Pulse Wave Velocity in Spinal Cord Injury and Stroke Patients
- ClinicalTrials.gov ID
- NCT00172289
- Acronym / sponsor ID
- 9261701395
- Conditions
- Cerebrovascular Accident, Spinal Cord Injury
- Keywords
- pulse wave velocity, sympathetic nerve activity, spinal cord injury, cerebrovascular accident
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Dec 2006
- First posted
- 15 Sep 2005 (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.
According to the theory of wave transmission, the speed of wave transmission is dependent on the nature of the transmission medium, which is the vessel wall for pulse wave transmission. Then, the pulse wave velocity is related to the mechanical property of the vessel wall. The mechanical property of the vessel wall is determined by the texture of the vessel wall and the contraction status of the smooth muscle within the vessel wall. Because the texture of the vessel wall could not be changed in a short duration, the sympathetic nerve activity, which controls the contractibility of the smooth muscle, becomes the only determinant factor of pulse wave velocity. So, pulse wave velocity may reflect the status of sympathetic nerve activity. The purpose of this project is to use the pulse wave velocity to measure the sympathetic activity of stroke and spinal cord patients. The present project plans to measure the pulse wave simultaneously at four limbs by pressure receptors, and use the electrocardiogram as the reference to synchronize the recorded pulse wave at different vessels, using the corrected data to calculate the pulse wave velocity. With the pulse wave velocity of different vessels, we, the investigators at National Taiwan University Hospital, can understand the local sympathetic nerve activity in different diseases and different sites.
The first year, we will set up the equipment for measuring the pulse wave velocity, and then apply it to 20 healthy subjects to adjust the measurement error and ascertain the reproducibility of the machine. The second year, we will apply the measurement to 15 complete cervical cord injury individuals and 15 healthy subjects in different erected angles by a tilting table. This procedure will make us understand the response of sympathetic nerve activity to different postures in normal subjects and cervical cord injury patients. The third year, we will apply the measurement to 30 cerebrovascular accident patients to understand the change of sympathetic nerve activity after having a stroke. By comparing the clinical information, we hope to clear up the relationship between sympathetic nerve activity and pulse wave velocity.
Detailed description
There are many diseases related to the dysfunction of sympathetic nerve activities in rehabilitation medicine. Shoulder hand syndrome, a common complication after having a cerebrovascular accident, is believed to combine with hyper-exciting of the sympathetic nerve at the lesion side. Autonomic dysfunction in spinal cord injury patients comes from the vicious cycle of local stimulation of the sympathetic nerve and results in the elevated blood pressure. Myofascial pain syndrome has been reported to have abnormal sympathetic activities in the late stage. Considering the above facts, accurate evaluation of sympathetic nerve activities is an important issue in rehabilitation practice.
Measuring the skin temperature and the status of local sweating are the common methods in evaluating the sympathetic nerve activity. However, many external environment factors would interfere with the result, and the accuracy of the result is questionable. Sympathetic skin reflex is the traditional electrodiagnostic method in measuring the sympathetic nerve activity, but its application is limited by poor reproducibility. Microneurography can measure the sympathetic nerve activity along the distribution of peroneus and bronchial nerves by inserting the needles into the above nerves, but its application is limited because of the invasive nature of the test.
When the heart is contracted, it pumps the blood into the peripheral vessels and transits a pulse wave along the vessel walls. The propagation velocity of the pulse wave is different from that of the blood flow. According to the theory of wave transmission, the speed of wave transmission is dependent on the nature of the transmission medium, which is the vessel wall for pulse wave transmission. Then, the pulse wave velocity is related to the mechanical property of the vessel wall. The mechanical property of the vessel wall is determined by the texture of the vessel wall and the contraction status of the smooth muscle within the vessel wall. Because the texture of the vessel wall could not be changed in a short duration, the sympathetic nerve activity, which controls the contractibility of the smooth muscle, becomes the only determinant factor of pulse wave velocity. So, pulse wave velocity may reflect the status of sympathetic nerve activity.
There were limited reports regarding the pulse wave velocity measurement and lack of reports of clinical application. The present project plans to measure the pulse wave simultaneously at four limbs by pressure receptors, and use the electrocardiogram as the reference to synchronize the recorded pulse wave at different vessels, using the corrected data to calculate the pulse wave velocity. With the pulse wave velocity of different vessels, we can understand the local sympathetic nerve activity in different diseases and different sites.
The first year, we will set up the equipment for measuring the pulse wave velocity, and then apply it to 20 healthy subjects to adjust the measurement error and ascertain the reproducibility of the machine. The second year, we will apply the measurement to 15 complete cervical cord injury individuals and 15 healthy subjects in different erected angles by a tilting table. This procedure will make us understand the response of sympathetic nerve activity to different postures in normal subjects and cervical cord injury patients. The third year, we will apply the measurement to 30 cerebrovascular accident patients to understand the change of sympathetic nerve activity after having a stroke. By comparing the clinical information, we hope to clear up the relationship between sympathetic nerve activity and pulse wave velocity.
The study will use the self-designed pulse wave velocity (PWV) machine to measure the patients with cerebrovascular accident (CVA) and spinal cord injury (SCI). The CVA patients will be divided into two groups with or without shoulder pain. The skin temperature and range of motion will be recorded. We hypothesize that the patients with shoulder pain may have higher sympathetic activity and will have higher speed of PWV. Sixty patients will be included. For SCI patients, we will compare the PWV of the upper extremity and lower extremity. We hypothesize that the cervical cord injury patients will have lower sympathetic tone below the lesion, and have lower speed of PWV when compared to the upper extremity.
Through this study, we will confirm the hypothesis that the PWV is an accurate method to measure the sympathetic activity and understand the change of sympathetic activity in CVA and SCI patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke patients with shoulder pain
- Spinal cord injury patients with complete cervical lesion
Key exclusion criteria (1 listed)
- Peripheral vascular disease
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2006.
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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.
Wang Tyng-Guey, MD study director
National Taiwan University, School of Medicine, National Taiwan University
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 Cerebrovascular Accident and Spinal Cord Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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 9 Jan 2006. 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 Taiwan. 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 Wang Tyng-Guey, MD (886-2-23123456 ext. 7588, tgw@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 Jan 2006.