Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy

NCT01373190 | Completed

• 1 other identifier: AU Epilepsy Study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Focal Onset Epilepsy; Partial Epilepsy

Keywords

epilepsy; thermography

Outcome Measures

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.

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

Secondary Outcomes (2)

• low back thermography imagery

  one time for thermographic imagery

• side thermography imagery

  one time for thermographic imagery

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Atlantic University: lead
• A.T. Still University of Health Sciences: collaborator

Study Sites (1)

Epilepsy Foundation of Florida

Miami, Florida, 33126, United States

Location

Related Publications (2)

• 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.

  PMID: 11805256 BACKGROUND

• 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.

  PMID: 15833692 BACKGROUND

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hollis H King, DO, PhD

  AT Still University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 14, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 21, 2013

Record last verified: 2011-06

Locations

US (1)