EpilepsyNCT00610558
Neocortical Epilepsies - Do They Progress?
A study testing Arm 1: Juvenile Myoclonic Epilepsy and Arm 2: Frontal Lobe Epilepsy in people with Epilepsy, run by University of California, Irvine at 1 site in United States.
Trial summary
This study will use MRI and PET scan to compare the brain imaging results between epilepsy patients and normal healthy controls, also to study changes in 3 years. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Arm 1: Juvenile Myoclonic Epilepsy and Arm 2: Frontal Lobe Epilepsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below).
- Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus
- History of myoclonic plus tonic-clonic or clonic-tonic-clonic seizures with or without absence seizures.
- EEG consistent with primary generalized epilepsy (>/= 3 c/s generalized, frontal maximum, poly spike and wave; normal alpha)
- Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus:
- Seizure semiology (behavior) consistent with FLE
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- Interictal EEG spikes consistent with FLE or
- Ictal video-EEG consistent with FLE
- Frontal lobe lesion of MRI
- Frontal hypometabolism on FDG-PET
Who cannot join
- History of seizures, faints, or any unexplained blackouts.
- Use of neuroleptic medications or sedating doses of antianxiety or antidepressant drugs.
- They should not have a clear family history of epilepsy (first degree relatives).
- History of any substance abuse within the past 5 years.
- History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
- History of stroke without complete recovery of neurologic function.
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- Pregnancy
- With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.
- Inability to understand the consent. (standard form attached)
- Inability to speak fluent English. Note: the neuropsychological tests are standardized for English speakers. They are not all available in multiple languages. Since the scoring and norms are established for English speakers, simply translating them would still not make the testing norms and scoring applicable.
- Juvenile Myoclonic Epilepsy (JME; 20 Subjects):
- History of significant head injury (> 30 min loss of consciousness)
- Use of neuroleptic drugs or sedative doses of antianxiety or antidepressant drugs
- History of any substance abuse within the past 5 years
- Presence of epileptogenic brain lesion on MRI (tumor, stroke, cortical congenital dysplasia, etc; excluding normal variants, mild subcortical white matter ischemic change, venous angiomas).
- EEG with focal epileptiform potentials or polymorphic slowing
- History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
- History of stroke without complete recovery of neurologic function.
- Pregnancy
- With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.
- Inability to speak fluent English
- Frontal Lobe Epilepsy (FLE; 20 Subjects):
- Presence of seizure semiology, ictal EEG, interictal EEG, MRI or PET findings that are not consistent with a frontal lobe epilepsy focus.
- Use of neuroleptic drugs or sedative doses of antianxiety or antidepressant drugs
- History of any substance abuse within the past 5 years
- History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
- History of stroke without complete recovery of neurologic function.
- Pregnancy
- With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.
- Absence of either a radial or ulnar arterial pulse
- Inability to speak fluent English
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Functional Onco-Imaging, University of California
Irvine, California, 92697
About this study
This study will use MRI and PET scan to compare the brain imaging results between epilepsy patients and normal healthy controls, also to study changes in 3 years.
Read the detailed description
We would like to continue analyzing the structural and metabolic differences between two epilepsy groups (JME and FLE) and the control to understand the imaging presentations of epilepsy patients
- Conditions
- Epilepsy
- Being tested
- Arm 1: Juvenile Myoclonic Epilepsy, Arm 2: Frontal Lobe Epilepsy, Arm 3: Normal Controls
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: Juvenile Myoclonic EpilepsyDevice
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Arm 2: Frontal Lobe EpilepsyDevice
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Arm 3: Normal ControlsDevice
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Juvenile Myoclonic Epilepsy | Experimental | Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment Receives: Device: Arm 1: Juvenile Myoclonic Epilepsy |
| Arm 2: Frontal Lobe Epilepsy | Experimental | Frontal Lobe Epilepsy group of subjects will participate for imaging assessment Receives: Device: Arm 2: Frontal Lobe Epilepsy |
| Arm 3: Normal Controls | Experimental | Normal Controls, eligible subjects don't have Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy will be placed in this group Receives: Device: Arm 3: Normal Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Connectivity
We will analyze the structural and metabolic differences between two epilepsy groups (JME and FLE) and understand the imaging presentations of epilepsy patients. We will process imaging requisition for Arm 1 and Arm 2 patients and the controls to examine if any differences in their brain image. The hypothesis is the functional connectivity between brainstem structures and cortical/subcortical regions may reflect in their imaging data. We would like to know if these imaging factors are related to epilepsy (JME and FLE) patients.
Measured: During Imaging Session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJul 2003
- Primary completionJun 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three different Groups in this study: Juvenile Myoclonic Epilepsy, Frontal Lobe Epilepsy, Normal Controls
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Ying (Lydia) Su, University of California, Irvine
- Investigators
- Min-Ying Su, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610558
- Sponsor's protocol ID
- UCI-HS-2003-3252
- Other IDs
- VA-821/103
- Status last verified
- Nov 2019
- First submitted
- 12 Jan 2008
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neocortical Epilepsies - Do They Progress?
- ClinicalTrials.gov ID
- NCT00610558
- Acronym / sponsor ID
- UCI-HS-2003-3252
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Posted 20 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use MRI and PET scan to compare the brain imaging results between epilepsy patients and normal healthy controls, also to study changes in 3 years.
Detailed description
We would like to continue analyzing the structural and metabolic differences between two epilepsy groups (JME and FLE) and the control to understand the imaging presentations of epilepsy patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three different Groups in this study: Juvenile Myoclonic Epilepsy, Frontal Lobe Epilepsy, Normal Controls
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Juvenile Myoclonic Epilepsy | Experimental | Device: Arm 1: Juvenile Myoclonic EpilepsyJuvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment |
| Arm 2: Frontal Lobe Epilepsy | Experimental | Device: Arm 2: Frontal Lobe EpilepsyFrontal Lobe Epilepsy group of subjects will participate for imaging assessment |
| Arm 3: Normal Controls | Experimental | Device: Arm 3: Normal ControlsNormal Controls, eligible subjects don't have Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy will be placed in this group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below).
- Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus
- History of myoclonic plus tonic-clonic or clonic-tonic-clonic seizures with or without absence seizures.
- EEG consistent with primary generalized epilepsy (>/= 3 c/s generalized, frontal maximum, poly spike and wave; normal alpha)
- Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus:
Key exclusion criteria (31 listed)
- History of seizures, faints, or any unexplained blackouts.
- Use of neuroleptic medications or sedating doses of antianxiety or antidepressant drugs.
- They should not have a clear family history of epilepsy (first degree relatives).
- History of any substance abuse within the past 5 years.
- History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1: Juvenile Myoclonic EpilepsyPositron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI | Device | Arm 1: Juvenile Myoclonic Epilepsy |
| Arm 2: Frontal Lobe EpilepsyPositron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI | Device | Arm 2: Frontal Lobe Epilepsy |
| Arm 3: Normal ControlsPositron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI | Device | Arm 3: Normal Controls |
Primary outcome
Functional Connectivity
Time frame: During Imaging Session
We will analyze the structural and metabolic differences between two epilepsy groups (JME and FLE) and understand the imaging presentations of epilepsy patients. We will process imaging requisition for Arm 1 and Arm 2 patients and the controls to examine if any differences in their brain image. The hypothesis is the functional connectivity between brainstem structures and cortical/subcortical regions may reflect in their imaging data. We would like to know if these imaging factors are related to epilepsy (JME and FLE) patients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Min-Ying Su, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: Juvenile Myoclonic Epilepsy and Arm 2: Frontal Lobe Epilepsy in people with Epilepsy, run by University of California, Irvine 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 10 inclusion and 31 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 20 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional Connectivity (time frame: During Imaging Session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2019.