Skip to main content
OpenTrials
Completed

NCT Number: NCT01373190

Thermographic Examination of Skin Temperatures in Individuals With 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Focal Onset Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases Partial Epilepsy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Epilepsy Foundation of Florida

Miami, Florida, 33126, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Experimental Group:

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

Exclusion criteria

Experimental Group:

  • Pregnancy
  • Recent trauma such as motor vehicle accident or injury to the musculoskeletal system
  • Currently on medication, other than for epilepsy which may affect autonomic nervous system function, e.g. Glaucoma medication
  • If diagnosed with a condition which could affect abdominal area neurophysiologic functions.
  • Irritable bowel syndrome
  • Crohn's disease
  • Ulcerative colitis
  • Migraine headache with abdominal manifestation

Inclusion criteria

Control group:

  • No history or diagnosis of any seizure disorder
  • Ages 18-70

Exclusion criteria

Control group:

  • Pregnancy
  • Recent trauma such as motor vehicle accident or injury to the musculoskeletal system
  • Currently on medication, other than for epilepsy which may affect autonomic nervous system function, e.g. Glaucoma medication
  • If diagnosed with a condition which could affect abdominal area neurophysiologic functions.
  • Irritable bowel syndrome
  • Crohn's disease
  • Ulcerative colitis
  • Migraine headache with abdominal manifestation

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Atlantic University

Other

Collaborators

  • A.T. Still University of Health Sciences

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2011
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.