Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Focal Onset Epilepsy Partial Epilepsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Thermographic Examination of Low Back and Abdominal Area Skin Temperatures in Individuals With and Without Focal Onset Epilepsy |
- 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 ] [ Designated as safety issue: No ]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.
- low back thermography imagery [ Time Frame: one time for thermographic imagery ] [ Designated as safety issue: No ]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
- side thermography imagery [ Time Frame: one time for thermographic imagery ] [ Designated as safety issue: No ]To capture possible dermatomal skin temperature effects will do thermographic imagery of the side or lateral aspect of the subjects.
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/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
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
50 individual with diagnosis of focal onset epilepsy 50 normal matched control subjects
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
Contacts and Locations| Contact: Patty Caamano, BA | 305-935-9206 | pcaamano@comcast.net |
| United States, Florida | |
| Epilepsy Foundation of Florida | Recruiting |
| Miami, Florida, United States, 33126 | |
| Principal Investigator: | Hollis H King, DO, PhD | AT Still University of Health Sciences |
More Information
Publications:
| Responsible Party: | Hollis H. King, DO, PhD, AT Still Univ School of Osteopathic Medicine in Arizona |
| ClinicalTrials.gov Identifier: | NCT01373190 History of Changes |
| Other Study ID Numbers: | AU Epilepsy Study |
| Study First Received: | June 2, 2011 |
| Last Updated: | June 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Atlantic University:
|
epilepsy thermography |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013