Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy

June 20, 2013 updated by: Hollis King, Atlantic University

Thermographic Examination of Low Back and Abdominal Area Skin Temperatures in Individuals With and Without Focal Onset Epilepsy

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33126
        • Epilepsy Foundation of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

50 individual with diagnosis of focal onset epilepsy 50 normal matched control subjects

Description

Inclusion Criteria Experimental Group:

  1. Diagnosis of Partial/Focal Onset Epilepsy (ICD9-CM 345.4 and 345.5)
  2. Ages 18-70

Exclusion Criteria Experimental Group:

  1. Pregnancy
  2. Recent trauma such as motor vehicle accident or injury to the musculoskeletal system
  3. Currently on medication, other than for epilepsy which may affect autonomic nervous system function, e.g. Glaucoma medication

  4. If diagnosed with a condition which could affect abdominal area neurophysiologic functions.

    1. Irritable bowel syndrome
    2. Crohn's disease
    3. Ulcerative colitis
    4. Migraine headache with abdominal manifestation

Inclusion criteria Control group:

  1. No history or diagnosis of any seizure disorder
  2. Ages 18-70

Exclusion Criteria Control group:

  1. Pregnancy
  2. Recent trauma such as motor vehicle accident or injury to the musculoskeletal system
  3. Currently on medication, other than for epilepsy which may affect autonomic nervous system function, e.g. Glaucoma medication

  4. If diagnosed with a condition which could affect abdominal area neurophysiologic functions.

    1. Irritable bowel syndrome
    2. Crohn's disease
    3. Ulcerative colitis
    4. Migraine headache with abdominal manifestation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Epilepsy Group
Individuals diagnosed with Partial/Focal Onset Epilepsy ICD9CM 345.4 and/or 345.5
Control Group
Individuals who do not have the diagnosis of Epilepsy and have no history of seizure disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thermographic imagery of the abdominal area
Time Frame: 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.
Each experimental subject and each control subject will be seen once for the administration of the thermography imagery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
low back thermography imagery
Time Frame: 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
one time for thermographic imagery
side thermography imagery
Time Frame: 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.
one time for thermographic imagery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic University

Collaborators

A.T. Still University of Health Sciences

Investigators

  • Principal Investigator: Hollis H King, DO, PhD, AT Still University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

June 2, 2011

First Submitted That Met QC Criteria

June 13, 2011

First Posted (ESTIMATE)

June 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU Epilepsy Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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