Cerebral Autoregulation in Patients With Epilepsy

Completed

• Conditions: Epilepsy

• Registration Number: NCT02775682
• Lead Sponsor: Yi Yang

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-18
• Status Verified: 2017-03
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
the consequence of electroencephalograph（EEG）	1 year

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China