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CAPE: Cerebral Autoregulation in Patients With Epilepsy

Sponsor
Yi Yang (Other)
Overall Status
Completed
CT.gov ID
NCT02775682
Collaborator
(none)
200
Enrollment
1
Location
13
Actual Duration (Months)
15.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cerebral Autoregulation in Patients With Epilepsy
    Actual Study Start Date :
    Apr 1, 2016
    Actual Primary Completion Date :
    May 1, 2017
    Actual Study Completion Date :
    May 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    patients with epilepsy
    normal individuals without epilepsy

    Outcome Measures

    Primary Outcome Measures

    1. phase difference(PD) in degree [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 [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 [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） [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients with epilepsy, as diagnosed by EEG
    Exclusion Criteria:

    • patients with status epilepticus

    • intracranial and/or extracranial major vascular stenosis/occlusion diagnosed by a transcranial Doppler (EMS-9PB, Delica, China) and carotid ultrasound (IU22, Phillips, Andover, MA)

    • a prior symptomatic cerebral vascular disease

    • a history of hypertension, cardiovascular disease, diabetes, hyperlipemia, current arrhythmia, hyperthyroidism, anemia and unstable blood pressure, which may undermine hemodynamic stability, or inability to cooperate sufficiently to complete the cerebral auto regulation examination

    • insufficient bilateral temporal bone windows for insonation of the middle cerebral artery

    • intolerance to cerebral autoregulation measurements

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Hospital of Jilin University Changchun Jilin China 130000

    Sponsors and Collaborators

    • Yi Yang

    Investigators

    • Study Chair: Yi Yang, MD,PhD, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yi Yang, Associated Dean of First Hospital of Jilin University, The First Hospital of Jilin University
    ClinicalTrials.gov Identifier:
    NCT02775682
    Other Study ID Numbers:
    • CA&EEG
    First Posted:
    May 18, 2016
    Last Update Posted:
    Aug 25, 2021
    Last Verified:
    Mar 1, 2017
    Keywords provided by Yi Yang, Associated Dean of First Hospital of Jilin University, The First Hospital of Jilin University
    epilepsy, dynamic cerebral autoregulation
    Additional relevant MeSH terms:
    Epilepsy

    Study Results

    No Results Posted as of Aug 25, 2021