Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy

This study has been completed.
Sponsor:
Collaborator:
A.T. Still University of Health Sciences
Information provided by (Responsible Party):
Hollis King, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01373190
First received: June 2, 2011
Last updated: June 20, 2013
Last verified: June 2011
  Purpose

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.


Condition
Focal Onset Epilepsy
Partial Epilepsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Thermographic Examination of Low Back and Abdominal Area Skin Temperatures in Individuals With and Without Focal Onset Epilepsy

Resource links provided by NLM:


Further study details as provided by Atlantic University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • low back thermography imagery [ Time Frame: one time for thermographic imagery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one time for thermographic imagery ] [ Designated as safety issue: No ]
    To capture possible dermatomal skin temperature effects will do thermographic imagery of the side or lateral aspect of the subjects.


Enrollment: 100
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373190

Locations
United States, Florida
Epilepsy Foundation of Florida
Miami, Florida, United States, 33126
Sponsors and Collaborators
Atlantic University
A.T. Still University of Health Sciences
Investigators
Principal Investigator: Hollis H King, DO, PhD AT Still University of Health Sciences
  More Information

Publications:
Responsible Party: Hollis King, Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01373190     History of Changes
Other Study ID Numbers: AU Epilepsy Study
Study First Received: June 2, 2011
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Atlantic University:
epilepsy
thermography

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014