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CompletedNCT01373190Updated Jun 21, 2013

Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy

An observational study in Focal Onset Epilepsy and Partial Epilepsy, sponsored by Atlantic University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-21.

Sponsored by Atlantic University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Focal Onset Epilepsy
  • Partial Epilepsy

Keywords

  • epilepsy
  • thermography
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In context

Epilepsy

1,806 studies on the registry are indexed under Epilepsy; 418 are open to participants now.

This study's enrollment of 100 is close to the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

This is the only study on the registry with Atlantic University as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Eligibility 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)

Groups and 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

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What researchers measure

Primary outcomes

  1. Thermographic imagery of the abdominal area

    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.

    Time frame: Each experimental subject and each control subject will be seen once for the administration of the thermography imagery

Secondary outcomes

  1. low back thermography 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

    Time frame: one time for thermographic imagery

  2. side thermography imagery

    To capture possible dermatomal skin temperature effects will do thermographic imagery of the side or lateral aspect of the subjects.

    Time frame: one time for thermographic imagery

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Study locations

1 site
  • Epilepsy Foundation of Florida
    Miami, Florida 33126, United States
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References and documents

Publications

  • Henkel A, Noachtar S, Pfander M, Luders HO. The localizing value of the abdominal aura and its evolution: a study in focal epilepsies. Neurology. 2002 Jan 22;58(2):271-6. doi: 10.1212/wnl.58.2.271. PubMed 11805256 ↗
  • Zinkin NT, Peppercorn MA. Abdominal epilepsy. Best Pract Res Clin Gastroenterol. 2005 Apr;19(2):263-74. doi: 10.1016/j.bpg.2004.10.001. PubMed 15833692 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01373190
Lead sponsor
Atlantic University
Collaborators
A.T. Still University of Health Sciences
Responsible party
Hollis King (Professor, University of Wisconsin, Madison) — Principal investigator
First posted
Jun 14, 2011
Start date
May 2011
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Jun 21, 2013

Study contacts

Hollis H King, DO, PhD
principal investigator · AT Still University of Health Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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