EpilepsyNCT01833247
Lactic Acidosis During and After Seizures
An observational study of Epilepsy, run by Stanford University at 1 site in United States.
Trial summary
This project looks at the time course of lactic acid rise (if any) after seizures. Salivary and capillary lactic acid are tested. This type of measurement may be useful in signalling the occurrence or recent history of a seizure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age range will be 18-75, men and women, all ethnic backgrounds to be eligible. Eligible population will be determined by who gets admitted to the epilepsy monitoring unit with a history of generalized tonic-clonic seizures.
Who may be able to join
- Age 18-75 inclusive.
- History of at least one generalized tonic-clonic (grand mal) seizure prior to enrollment in the study.
- Undergoing monitoring in the Stanford Epilepsy Monitoring Unit.
Who cannot join
- Not pregnant.
- Inability to understand and sign the consent form.
- No known history of mitochondrial disease or other metabolic disorders expected to affect blood lactate.
- No known history of thrombophlebitis or excessive tendency to bleeding. Not on coumadin. Aspirin or anti-platelet agents are not an exclusion.
- No known peripheral vascular disease affecting blood circulation to the fingers.
- No painful peripheral neuropathy.
- No Raynaud's disease or phenomenon.
Trial locations and contacts
1 site in 1 country.
About this study
This project looks at the time course of lactic acid rise (if any) after seizures. Salivary and capillary lactic acid are tested. This type of measurement may be useful in signalling the occurrence or recent history of a seizure.
Read the detailed description
Lactic acid is released from cells during seizures and elevates lactic acid levels in blood and saliva. The time course of this rise is unknown. If lactic acid rises within a few minutes of a seizure, than it might be feasible to develop lactic acid sensors to provide notification of a recent seizure. This could lead to better safety monitoring for people with epilepsy. This study was designed to utilize a commercially available lactic acid sensor (investigators have no connection with the sensor manufacturer and purchased the device at list price) to measure salivary lactic acid levels after a seizure during inpatient video-EEG epilepsy monitoring.
- Conditions
- Epilepsy
- Keywords
- epilepsy, lactic acid, saliva, postictal
- 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 |
|---|---|---|
| Epilepsy inpatients | Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Lactic Acid Levels With Seizures
The investigators will assess the salivary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in saliva , immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.
Measured: Within 10 minutes of end of the seizure
Capillary Lactic Acid Levels With Seizures
The investigators will assess the capillary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in blood, within 10 minutes after the end of a seizure. Units of measurement will be mM/L. Baseline lactate serum level is expected to be less than 2.2 mM/L.
Measured: Within 10 minutes of end of the seizure
Intravenous Lactic Acid Levels With Seizures
The investigators will assess the intravenous lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in serum collected by IV, immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.
Measured: Within 10 minutes of end of the seizure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert S. Fisher, M.D., Ph.D., Stanford University
- Investigators
- Robert S Fisher, MD, PhD, Principal investigator, Stanford University Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833247
- Sponsor's protocol ID
- Stanford Epilepsy IRB 21989
- Status last verified
- May 2017
- First submitted
- 28 Mar 2013
- Last updated
- 5 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: If subjects wish to know their lactic acid levels after a seizure, we will provide the information, although it currently has no therapeutic or prognostic implications.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactic Acidosis During and After Seizures
- ClinicalTrials.gov ID
- NCT01833247
- Acronym / sponsor ID
- Stanford Epilepsy IRB 21989
- Conditions
- Epilepsy
- Keywords
- epilepsy, lactic acid, saliva, postictal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project looks at the time course of lactic acid rise (if any) after seizures. Salivary and capillary lactic acid are tested. This type of measurement may be useful in signalling the occurrence or recent history of a seizure.
Detailed description
Lactic acid is released from cells during seizures and elevates lactic acid levels in blood and saliva. The time course of this rise is unknown. If lactic acid rises within a few minutes of a seizure, than it might be feasible to develop lactic acid sensors to provide notification of a recent seizure. This could lead to better safety monitoring for people with epilepsy. This study was designed to utilize a commercially available lactic acid sensor (investigators have no connection with the sensor manufacturer and purchased the device at list price) to measure salivary lactic acid levels after a seizure during inpatient video-EEG epilepsy monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy inpatients | – | –Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age range will be 18-75, men and women, all ethnic backgrounds to be eligible. Eligible population will be determined by who gets admitted to the epilepsy monitoring unit with a history of generalized tonic-clonic seizures.
Key inclusion criteria (3 listed)
- Age 18-75 inclusive.
- History of at least one generalized tonic-clonic (grand mal) seizure prior to enrollment in the study.
- Undergoing monitoring in the Stanford Epilepsy Monitoring Unit.
Key exclusion criteria (7 listed)
- Not pregnant.
- Inability to understand and sign the consent form.
- No known history of mitochondrial disease or other metabolic disorders expected to affect blood lactate.
- No known history of thrombophlebitis or excessive tendency to bleeding. Not on coumadin. Aspirin or anti-platelet agents are not an exclusion.
- No known peripheral vascular disease affecting blood circulation to the fingers.
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
Salivary Lactic Acid Levels With Seizures
Time frame: Within 10 minutes of end of the seizure
The investigators will assess the salivary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in saliva , immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.
Capillary Lactic Acid Levels With Seizures
Time frame: Within 10 minutes of end of the seizure
The investigators will assess the capillary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in blood, within 10 minutes after the end of a seizure. Units of measurement will be mM/L. Baseline lactate serum level is expected to be less than 2.2 mM/L.
Intravenous Lactic Acid Levels With Seizures
Time frame: Within 10 minutes of end of the seizure
The investigators will assess the intravenous lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in serum collected by IV, immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. If subjects wish to know their lactic acid levels after a seizure, we will provide the information, although it currently has no therapeutic or prognostic implications.
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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.
Robert S Fisher, MD, PhD principal investigator
Stanford University Department of Neurology
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 Stanford University at 1 site in United States.
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 3 inclusion and 7 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 5 May 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Salivary Lactic Acid Levels With Seizures (time frame: Within 10 minutes of end of the seizure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2017.