Clinical trial NCT02775682: Cerebral Autoregulation in Patients With Epilepsy
Official title: Cerebral Autoregulation in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy, dynamic cerebral autoregulation
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: phase difference(PD) in degree
timeFrame: 1 year
Secondary outcomes:
measure: the rate of recovery of cerebral blood flow velocity
timeFrame: 1 year
measure: gain in cm/s/mmHg
timeFrame: 1 year
measure: the consequence of electroencephalograph（EEG）
timeFrame: 1 year
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
name: Yi Yang, MD,PhD
role: STUDY_CHAIR
References:
citation: Lv S, Guo ZN, Jin H, Sun X, Jia M, Ma H, Lv Y, Qiu Q, Liu J, Yang Y. Compromised Dynamic Cerebral Autoregulation in Patients with Epilepsy. Biomed Res Int. 2018 Feb 7;2018:6958476. doi: 10.1155/2018/6958476. eCollection 2018.