Neuroimaging Predictors of Treatment Failure in Adult New-onset Epilepsy
NCT ID: NCT01320670
Last Updated: 2013-01-21
Study Results
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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UNKNOWN
50 participants
OBSERVATIONAL
2011-06-30
2014-12-31
Brief Summary
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We do not understand why a significant proportion of people with epilepsy have PR. For any given patient presenting with a first unprovoked seizure, we are unable to predict PR at the time of presentation. At least 2 different AEDs must be tried at maximum doses for a year before we can diagnose PR. At this point, surgical therapies become an increasingly urgent consideration.
Retrospective magnetic resonance imaging (MRI) studies in the chronic stages of epilepsy have shown that patients with PR are more likely to have focal structural lesions in the brain, and in particular to have signs of damage to the hippocampi. For example, there are retrospective data suggesting that a decreased hippocampal N-acetylaspartate (NAA)/creatine ratio (measured by magnetic resonance spectroscopy \[MRS\]) and hippocampal atrophy (determined by hippocampal volumetry) correlate with PR. However, it is not clear whether these findings reflect the underlying pathophysiology of PR, or simply reflect the effects of chronic seizures and chronic drug treatment on the brain.
The First Seizure Clinic at the Halifax Infirmary represents a unique opportunity for prospective, longitudinal studies of patients who present with a first seizure or with newly diagnosed epilepsy. In these patients, advanced neuroimaging techniques at presentation might show changes that truly reflect the underlying pathophysiology of PR, rather than changes that develop as a consequence of prolonged seizures and drug treatment. Neuroimaging follow-up might help us to understand the pathophysiologic changes that accompany the evolution of PR. Ultimately, it is our hope to combine neuroimaging features and clinical features of patients with PR in a predictive model that would help us to predict PR at presentation.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed epilepsy or history of first unprovoked, witnessed seizure
Exclusion Criteria
* Acute lesion on CT (e.g. stroke, hemorrhage
* Provoked seizure due to obvious, chronic lesion on CT (e.g. vascular malformation, tumour)
* Progressive brain disease (e.g. neoplastic, infectious, demyelinating diseases)
* History of epilepsy longer than 1 year at presentation to FSC
* History of AED treatment for more than 4 weeks
* Contraindication to MRI
17 Years
ALL
No
Sponsors
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Nova Scotia Health Research Foundation
OTHER_GOV
Nova Scotia Health Authority
OTHER
Responsible Party
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Bernd Pohlmann-Eden
Professor
Principal Investigators
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Bernd Pohlmann-Eden, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Capital Health, Canada
Locations
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Halifax Infirmary
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Campos BA, Yasuda CL, Castellano G, Bilevicius E, Li LM, Cendes F. Proton MRS may predict AED response in patients with TLE. Epilepsia. 2010 May;51(5):783-8. doi: 10.1111/j.1528-1167.2009.02379.x. Epub 2009 Oct 20.
Other Identifiers
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1164
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CDHA-RS/2011-258
Identifier Type: -
Identifier Source: org_study_id
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