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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epilepsy inpatients | Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Within 10 minutes of end of the seizure |
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Fisher, MD, PhD | Stanford University Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital | Stanford | California | 94305-5235 | United States |
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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| ID | Title | Description |
|---|---|---|
| FG000 | Epilepsy Inpatients | Patients who have blood or salivary (or both) levels recorded after a seizure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients with epilepsy in hospital for video-EEG recording
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| ID | Title | Description |
|---|---|---|
| BG000 | Epilepsy Inpatients | Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mmol/L | Within 10 minutes of end of the seizure |
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Within 2 hours after the seizure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epilepsy Inpatients | Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure. |
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Salivary lactic acid levels were difficult to reliably obtain with commercial devices designed to measure blood salivary levels. Because of low reliability, we did not pursue the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert S. Fisher, MD, PhD | Stanford University Department of Neurology | 650-7215289 | robert.fisher@stanford.edu |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 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. | Data were collected from 6 of the 12 enrolled subjects | Posted | Mean | Standard Deviation | mmol/L | Within 10 minutes of end of the seizure |
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| 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. | Data were collected from one participant | Posted | Number | mmol/L | Within 10 minutes of end of the seizure |
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| 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. | Not Posted | Within 10 minutes of a seizure | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
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