Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy

Completed

• Conditions: Focal Onset Epilepsy; Partial Epilepsy

• Registration Number: NCT01373190
• Lead Sponsor: Atlantic University

Brief Summary

The specific aim is to determine if there are patterns of temperature differences in the abdominal and back regions of individuals with partial/focal onset epilepsy as compared to a non-epileptic control group. The hypothesis is that individuals with partial/focal onset epilepsy will have colder recorded temperatures in the abdominal area than individuals in a matched control group.

Detailed Description

The concept of "Abdominal Epilepsy" has been described in the neurology literature. The present study seeks to amplify understanding of this clinical entity by measuring abdominal area and low back skin temperature changes which may be affected through the function of the abdominal ganglia, specifically the Celiac, Superior Mesenteric and Inferior Mesenteric Ganglia.

This not an intervention study. It is study comparing abdominal area and low back skin temperature in individuals with the Partial/Focal Onset Epilepsy with a match control group of individuals with no epilepsy history. The implications of the outcome of the finding any significant temperature changes between the experimental and control groups is great enough to warrant the highest level of scientific scrutiny that this registration permits.

Study Timeline

• Study Start: 2011-05
• Status Verified: 2011-06
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thermographic imagery of the abdominal area	Each experimental subject and each control subject will be seen once for the administration of the thermography imagery	State of the art thermographic imagery of the imagery of the abdominal area from the xyphoid bone to just above the public symphysis. It is hypothesized that the average temperature for the experimental group will be lower than the control group. Since this is a measurement or diagnostic study using thermographic imagery, there is no health risk to the subjects.

Secondary Outcome Measures

Name	Time	Method
low back thermography imagery	one time for thermographic imagery	Besides abdominal area will also do theographic imagery of low back of subjects because of the possibility of dermatomal skin area temperature changes possibly related the "Abdominal Epilepsy" dysfunction of the Celiac, Superior Mesenteric and Inferior Mesenteric Ganglia
side thermography imagery	one time for thermographic imagery	To capture possible dermatomal skin temperature effects will do thermographic imagery of the side or lateral aspect of the subjects.

Trial Locations

Locations (1)

Epilepsy Foundation of Florida; 🇺🇸 Miami, Florida, United States