Neuroimaging Predictors of Treatment Failure in Adult New-onset Epilepsy
2 other identifiers
observational
50
1 country
1
Brief Summary
Epilepsy, defined as recurrent, unprovoked seizures, is a common condition, affecting 0.5-1% of the general population. People with uncontrolled epilepsy suffer poor health and increased mortality due to their condition. They frequently experience social stigma and are socioeconomically disadvantaged. It is therefore imperative to help them gain control of their seizures as quickly as possible. A wide range of antiepileptic drugs (AEDs) has become available to treat people with epilepsy. However, despite maximal therapy, approximately 20-40% show pharmacoresistance (PR) and thus continue to have seizures. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 21, 2013
January 1, 2013
3 years
March 21, 2011
January 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacoresistance
At the end of the study, each participant will be categorized as "PR" or "not PR" by the principal investigator. Participants will be categorized as PR if they have not achieved seizure freedom within 1 year of therapy, using at least 2 AEDs at maximal dose.
12 months
Secondary Outcomes (1)
Hippocampal NAA/creatine ratio
12 months
Eligibility Criteria
Patients with first seizure or new-onset epilepsy aged \> 17 years
You may qualify if:
- Age 17 years
- Newly diagnosed epilepsy or history of first unprovoked, witnessed seizure
You may not qualify if:
- Lack of consent provoked seizure due to obvious
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7, Canada
Related Publications (1)
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.
PMID: 19845737BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernd Pohlmann-Eden, MD, PhD
Capital Health, Canada
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 21, 2011
First Posted
March 22, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
January 21, 2013
Record last verified: 2013-01