Recruiting
Phase 2

Observational Study

Sponsor:

University of South Florida

Code:

NCT03202082

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Neuropsychological testing

Study Details

Brief summary:

The present study aims to expand the evidence base of neuropsychological services in the context of medical management of epilepsy, examining whether treatment outcome and patient satisfaction with medical care are significantly improved when neuropsychological evaluation is included as an additional component of medical care within a comprehensive epilepsy center. All participants will complete an initial survey and a follow-up survey regarding views towards their epilepsy treatment. Participants will be randomized into one of two groups. One group will be given a neuropsychological battery in addition to the survey. The primary study hypothesis is that the addition of neuropsychological services to treatment-as-usual will result in significant improvements in (a) satisfaction with medical care, (b) patient perceived treatment outcome, and (c) physician-rated medical compliance. The secondary hypothesis is that participants who undergo neuropsychological evaluation will be generally satisfied with their experience with neuropsychological services.

Conditions

Epilepsy

Study ID

NCT03202082

Start date

Jul 1, 2015

Status verified date

Jun, 2017

Completion date

Jun 30, 2018

Anticipated

Primary completion date

Jun 30, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age or older
  • experiencing some degree of epilepsy-related symptoms, but not of such severity as to preclude them from being able to provide consent or undergo neuropsychological assessment (requiring extended inpatient treatment, severely aphasic, or MMSE score < 25)

Exclusion Criteria:

  • Previously undergone neuropsychological testing
  • Currently pursuing surgical treatment for epilepsy

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Neuropsychological testing

Participants from this group will be administered a neuropsychological battery in addition to the initial and follow-up surveys

no intervention: Treatment as usual

Participants from this group will be administered the initial and follow-up survey.

Interventions

Neuropsychological testing

Neuropsychological testing evaluates various aspects of a participants cognitive ability as well as mood.

Primary outcome measure

  • Epilepsy Outcome Study Survey [ Time Frame: 2-4 months ]

Central Contacts and Locations

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Mike R Schoenberg, Ph.D

813-974-8900mschoenb@health.usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Jun 28, 2017

Last verified

Jun, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2017-06-28.