EpilepsyCAPENCT02775682
Cerebral Autoregulation in Patients With Epilepsy
An observational study of Epilepsy, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to determine whether patients with epilepsy exhibiting impaired dCA, which may contribute to subsequent stroke. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- patients with epilepsy, as diagnosed by EEG
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether patients with epilepsy exhibiting impaired dCA, which may contribute to subsequent stroke.
Read the 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.
- Conditions
- Epilepsy
- Keywords
- epilepsy, dynamic cerebral autoregulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with epilepsy | Not described | |
| normal individuals without epilepsy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
gain in cm/s/mmHg
A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as primary outcome
Measured: 1 year
the consequence of electroencephalograph（EEG）
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, MD,PhD, Study chair, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775682
- Sponsor's protocol ID
- CA&EEG
- Acronym
- CAPE
- Status last verified
- Mar 2017
- First submitted
- 13 May 2016
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29568762
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Autoregulation in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT02775682
- Acronym / sponsor ID
- CAPE / CA&EEG
- Conditions
- Epilepsy
- Keywords
- epilepsy, dynamic cerebral autoregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with epilepsy | – | – |
| normal individuals without epilepsy | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients with epilepsy, as diagnosed by EEG
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
phase difference(PD) in degree
Time frame: 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.
3 secondary outcomes
the rate of recovery of cerebral blood flow velocity
Time frame: 1 year
gain in cm/s/mmHg
Time frame: 1 year
the consequence of electroencephalograph（EEG）
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 29568762Lv 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Yang, MD,PhD study chair
Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Yi Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phase difference(PD) in degree (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02775682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.