Clinical trial NCT01373190: Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy
Official title: Thermographic Examination of Low Back and Abdominal Area Skin Temperatures in Individuals With and Without Focal Onset Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focal Onset Epilepsy
Partial Epilepsy
Keywords: epilepsy
thermography
Lead sponsor: Atlantic University
Sponsor class: OTHER
Collaborators: name: A.T. Still University of Health Sciences
First posted: 2011-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 individual with diagnosis of focal onset epilepsy 50 normal matched control subjects

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.

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

Primary outcomes:
measure: Thermographic imagery of the abdominal area
timeFrame: Each experimental subject and each control subject will be seen once for the administration of the thermography imagery
Secondary outcomes:
measure: low back thermography imagery
timeFrame: one time for thermographic imagery
measure: side thermography imagery
timeFrame: one time for thermographic imagery
Other outcomes:
Locations:
city: Miami
country: United States
facility: Epilepsy Foundation of Florida
state: Florida
Study officials:
affiliation: AT Still University of Health Sciences
name: Hollis H King, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.