Cerebral Autoregulation in Patients With Epilepsy

Epilepsy Clinical Trial

— CAPE  

Official title:

Cerebral Autoregulation in Patients With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775682
• Other study ID #: CA&EEG
• Status: Completed
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: March 2017
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phase difference(PD) in degree	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.	1 year
Secondary	the rate of recovery of cerebral blood flow velocity	A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as primary outcome	1 year
Secondary	gain in cm/s/mmHg	A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as primary outcome	1 year
Secondary	the consequence of electroencephalograph(EEG)		1 year