Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy

NCT ID: NCT01373190

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Focal Onset Epilepsy Partial Epilepsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Epilepsy Group

Individuals diagnosed with Partial/Focal Onset Epilepsy ICD9CM 345.4 and/or 345.5

No interventions assigned to this group

Control Group

Individuals who do not have the diagnosis of Epilepsy and have no history of seizure disorders

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


1. No history or diagnosis of any seizure disorder
2. Ages 18-70

Exclusion Criteria

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


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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A.T. Still University of Health Sciences

OTHER

Sponsor Role collaborator

Atlantic University

OTHER

Sponsor Role lead

Responsible Party

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Hollis King

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hollis H King, DO, PhD

Role: PRINCIPAL_INVESTIGATOR

AT Still University of Health Sciences

Locations

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Epilepsy Foundation of Florida

Miami, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11805256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15833692 (View on PubMed)

Other Identifiers

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AU Epilepsy Study

Identifier Type: -

Identifier Source: org_study_id

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