Epilepsy
Conditions
Keywords
epilepsy, lactic acid, saliva, postictal
Brief 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.
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.
Interventions
None listed
Sponsors
Stanford University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 inclusive. 2. History of at least one generalized tonic-clonic (grand mal) seizure prior to enrollment in the study. 3. Undergoing monitoring in the Stanford Epilepsy Monitoring Unit.
Exclusion criteria
4. Not pregnant. 5. Inability to understand and sign the consent form. 6. No known history of mitochondrial disease or other metabolic disorders expected to affect blood lactate. 7. No known history of thrombophlebitis or excessive tendency to bleeding. Not on coumadin. Aspirin or anti-platelet agents are not an exclusion. 8. No known peripheral vascular disease affecting blood circulation to the fingers. 9. No painful peripheral neuropathy. 10. No Raynaud's disease or phenomenon.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Lactic Acid Levels With Seizures | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epilepsy Inpatients Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Epilepsy Inpatients |
|---|---|
| Age, Continuous | 40.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: Within 10 minutes of end of the seizure
Population: Data were collected from 6 of the 12 enrolled subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epilepsy Inpatients | Capillary Lactic Acid Levels With Seizures | 5.67 mmol/L | Standard Deviation 4.57 |
Primary
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.
Time frame: Within 10 minutes of end of the seizure
Population: Data were collected from one participant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epilepsy Inpatients | Intravenous Lactic Acid Levels With Seizures | 8.6 mmol/L |
Primary
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.
Time frame: Within 10 minutes of end of the seizure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epilepsy Inpatients | Salivary Lactic Acid Levels With Seizures | 8.16 mmol/L | Standard Deviation 8.88 |
Post Hoc
Salivary and Capillary Lactic Acid Will be Correlated After a Seizure
Salivary levels of lactic acid is being studied because saliva is more accessible in the outpatient setting than is blood. Concentration of lactic acid in the serum and saliva from each individual subject will be correlated using Pearson's correlation test. We will consider a positive outcome to be a r greater than or equal to 0.5 and significance at p\<0.05.
Time frame: Within 10 minutes of a seizure