NCT02775682

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 25, 2021

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

May 13, 2016

Last Update Submit

August 19, 2021

Conditions

Keywords

epilepsy, dynamic cerebral autoregulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • the rate of recovery of cerebral blood flow velocity

    1 year

  • gain in cm/s/mmHg

    1 year

  • the consequence of electroencephalograph(EEG)

    1 year

Study Arms (2)

patients with epilepsy

normal individuals without epilepsy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • patients with epilepsy, as diagnosed by EEG

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Yi Yang, MD,PhD

    Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Dean of First Hospital of Jilin University

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 18, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 25, 2021

Record last verified: 2017-03

Locations