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Trial record 1 of 1482 for:    "Epilepsy" OR "pyridoxal 5'-phosphate-dependent epilepsy"
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Cerebral Autoregulation in Patients With Epilepsy (CAPE)

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ClinicalTrials.gov Identifier: NCT02775682
Recruitment Status : Recruiting
First Posted : May 18, 2016
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Yi Yang, First Hospital of Jilin University

Brief Summary:
The purpose of this study is to determine whether patients with epilepsy exhibiting impaired dCA, which may contribute to subsequent stroke.

Condition or disease
Epilepsy

Detailed Description:
The relationship between epileptic seizures and cerebrovascular disease is complex, ranging from mechanisms to clinical manifestation. Stroke is one of the most common causes of epilepsy in adulthood. It was also reported that patients with epilepsy exhibited a higher risk of stroke. But its potential mechanism was never fully understood. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral bold flow, has been proved to be critical for the occurrence ,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that impaired dCA play a role in epilepsy and subsequent stroke.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cerebral Autoregulation in Patients With Epilepsy
Study Start Date : April 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort
patients with epilepsy
normal individuals without epilepsy



Primary Outcome Measures :
  1. phase difference(PD) in degree [ Time Frame: 1 year ]
    A dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.


Secondary Outcome Measures :
  1. the rate of recovery of cerebral blood flow velocity [ Time Frame: 1 year ]
    A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as primary outcome

  2. gain in cm/s/mmHg [ Time Frame: 1 year ]
    A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as primary outcome

  3. the consequence of electroencephalograph(EEG) [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with a diagnosis of epilepsy were recruited from the Department of Neurology, First Hospital of Jilin University, China. Patient was diagnosed with epilepsy by two neurologists according to the consequence of EEG.
Criteria

Inclusion Criteria:

  • patients with epilepsy, as diagnosed by EEG

Exclusion Criteria:

  • middle cerebral artery (MCA) and/or other intracranial and/or extracranial major vascular stenosis/occlusion, as diagnosed by a transcranial Doppler
  • having a prior symptomatic cerebrovascular disease
  • having a history of hypertension, diabetes, or hyperlipemia
  • current arrhythmia, hyperthyroidism, anemia and unstable blood pressure, which may undermine hemodynamic stability
  • inability to cooperate sufficiently to complete the dCA examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775682


Contacts
Contact: Yi Yang, MD,PhD doctor_yangyi@hotmail.com
Contact: Zhenni Guo, MD zhen1ni2@163.com

Locations
China, Jilin
First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130000
Contact: Yi Yang, M.D. PhD.    +86-18186870008    doctoryangyi@163.com   
Sponsors and Collaborators
Yi Yang
Investigators
Study Chair: Yi Yang, MD,PhD Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yi Yang, Associated Dean of First Hospital of Jilin University, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT02775682     History of Changes
Other Study ID Numbers: CA&EEG
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Yi Yang, First Hospital of Jilin University:
epilepsy, dynamic cerebral autoregulation

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases