Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy

Partial Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373190
• Other study ID #: AU Epilepsy Study
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: June 20, 2013
• Start date: May 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2011
• Source: Atlantic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Onset Epilepsy
• Partial Epilepsy

Locations

Country	Name	City	State
United States	Epilepsy Foundation of Florida	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Atlantic University	A.T. Still University of Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (2)

Henkel A, Noachtar S, Pfänder M, Lüders HO. The localizing value of the abdominal aura and its evolution: a study in focal epilepsies. Neurology. 2002 Jan 22;58(2):271-6. — View Citation

Zinkin NT, Peppercorn MA. Abdominal epilepsy. Best Pract Res Clin Gastroenterol. 2005 Apr;19(2):263-74. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Each experimental subject and each control subject will be seen once for the administration of the thermography imagery	No
Secondary	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	one time for thermographic imagery	No
Secondary	side thermography 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	No