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Clinical Trials/NCT01130649
NCT01130649
Withdrawn
Not Applicable

Pilot Study of Real-time Automated Tracking System for Patients With Epilepsy

University of California, San Francisco1 site in 1 countryJuly 2010
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
University of California, San Francisco
Locations
1
Primary Endpoint
Quality of life
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief Summary

The investigators propose a novel method for tracking the seizure frequency, side effect burden, and medication compliance for patients with epilepsy. The investigators intend to utilize a table-top device currently for tracking other chronic disease to collect remote data from epilepsy patients. The hypothesis is that the use of this device will lead to better longterm treatment outcomes than the standard outpatient mechanism of following patients longitudinally.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
July 2013
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Hixson

Associate Professor of Neurology

University of California, San Francisco

Eligibility Criteria

Inclusion Criteria

  • Eligible participants must have a definitive diagnosis of epilepsy for at least 6 months, based on the clinical judgement of the investigators. Epilepsy is defined by two or more unprovoked seizures. Clinical history, electroencephalography, and imaging data are all instrumental in rendering a formal decision. The seizure type, frequency, or severity are not criteria for exclusion, although this information will be recorded.
  • Patient can range in age from birth to 65 years old; in cases of child participants, the parents are responsible for data reporting.
  • Patients must have a seizure frequency of at least two seizures in a 6 month period of time.
  • Patients must be on at least one anti-epileptic medication.
  • Patients and/or legal guardian must be able to report seizure frequency with either a paper or electronic diary.
  • Patients and/or legal guardians must be able to read and understand either English or Spanish.
  • Patients and/or legal guardians must be able to complete questionnaires and provide informed consent to this study.

Exclusion Criteria

  • Exclusion criteria include: a diagnosis of psychogenic nonepileptic seizures; severe depression, anxiety, or psychosis
  • Recent problem with substance abuse.

Outcomes

Primary Outcomes

Quality of life

Time Frame: 1 year

Quality of Life in Epilepsy inventory, to assess for overall change in quality of life measures

Seizure frequency per month

Time Frame: 1 year

Assessment of seizure count accuracy by assessing total number of seizures reported per month

Medication compliance

Time Frame: 1 year

Assessment of compliance with taking medications at regularly scheduled intervals

Study Sites (1)

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