Lactic Acidosis During and After Seizures

NCT ID: NCT01833247

Last Updated: 2017-05-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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

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Epilepsy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Epilepsy inpatients

Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Robert S. Fisher, M.D., Ph.D.

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert S Fisher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University Department of Neurology

Locations

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Stanford Hospital

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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Stanford Epilepsy IRB 21989

Identifier Type: -

Identifier Source: org_study_id

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