Focal Onset EpilepsyNCT01373190
Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy
An observational study of Focal Onset Epilepsy and Partial Epilepsy, run by Atlantic University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Focal Onset Epilepsy, Partial Epilepsy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 individual with diagnosis of focal onset epilepsy 50 normal matched control subjects
Who may be able to join
- Diagnosis of Partial/Focal Onset Epilepsy (ICD9-CM 345.4 and 345.5)
- Ages 18-70
- No history or diagnosis of any seizure disorder
- Ages 18-70
Who cannot join
- 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
Show all 16Show fewer
- Ulcerative colitis
- Migraine headache with abdominal manifestation
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Epilepsy Foundation of Florida
Miami, Florida, 33126
About this study
Official title: Thermographic Examination of Low Back and Abdominal Area Skin Temperatures in Individuals With and Without Focal Onset Epilepsy
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.
Read the 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.
- Conditions
- Focal Onset Epilepsy, Partial Epilepsy
- Keywords
- epilepsy, thermography
- Medical subject headings
- Epilepsies, Partial, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: one time for thermographic imagery
side thermography imagery
To capture possible dermatomal skin temperature effects will do thermographic imagery of the side or lateral aspect of the subjects.
Measured: one time for thermographic imagery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Focal Onset EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic University
- Sponsor type
- University, hospital or other
- Collaborators
- A.T. Still University of Health Sciences
- Responsible party
- Principal investigator, Hollis King, University of Wisconsin, Madison
- Investigators
- Hollis H King, DO, PhD, Principal investigator, AT Still University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373190
- Sponsor's protocol ID
- AU Epilepsy Study
- Status last verified
- Jun 2011
- First submitted
- 2 Jun 2011
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11805256Zinkin NT, Peppercorn MA. Abdominal epilepsy. Best Pract Res Clin Gastroenterol. 2005 Apr;19(2):263-74. doi: 10.1016/j.bpg.2004.10.001.
PubMed 15833692
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermographic Examination of Low Back and Abdominal Area Skin Temperatures in Individuals With and Without Focal Onset Epilepsy
- ClinicalTrials.gov ID
- NCT01373190
- Acronym / sponsor ID
- AU Epilepsy Study
- Conditions
- Focal Onset Epilepsy, Partial Epilepsy
- Keywords
- epilepsy, thermography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Atlantic UniversityUniversity, hospital or other
- Collaborators
- A.T. Still University of Health Sciences
- Study start
- May 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 individual with diagnosis of focal onset epilepsy 50 normal matched control subjects
Key inclusion criteria (4 listed)
- Diagnosis of Partial/Focal Onset Epilepsy (ICD9-CM 345.4 and 345.5)
- Ages 18-70
- No history or diagnosis of any seizure disorder
- Ages 18-70
Key exclusion criteria (16 listed)
- 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.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
2 secondary outcomes
low back thermography imagery
Time frame: one time for thermographic imagery
side thermography imagery
Time frame: one time for thermographic imagery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Background: PubMed 11805256Henkel 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.
- Background: PubMed 15833692Zinkin NT, Peppercorn MA. Abdominal epilepsy. Best Pract Res Clin Gastroenterol. 2005 Apr;19(2):263-74. doi: 10.1016/j.bpg.2004.10.001.
Related trials for Focal Onset Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
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SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
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Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
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A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollis H King, DO, PhD principal investigator
AT Still University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Onset Epilepsy and Partial Epilepsy, run by Atlantic University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373190, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.