Neuroimaging Predictors of Treatment Failure in Adult New-onset Epilepsy

NCT ID: NCT01320670

Last Updated: 2013-01-21

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy Seizures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age 17 years
* Newly diagnosed epilepsy or history of first unprovoked, witnessed seizure

Exclusion Criteria

* 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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nova Scotia Health Research Foundation

OTHER_GOV

Sponsor Role collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Bernd Pohlmann-Eden

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Bernhard Pohlmann-Eden, MD, PhD

Role: CONTACT

902-473-1882

Matthias H Schmidt, MD

Role: CONTACT

902-473-5332

Facility Contacts

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Bernhard Pohlmann-Eden, MD, PhD

Role: primary

902-473-1882

Matthias H Schmidt, MD

Role: backup

902-473-5332

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.

Reference Type BACKGROUND
PMID: 19845737 (View on PubMed)

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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