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Impact of Neuropsychological Evaluation on Epilepsy Treatment

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ClinicalTrials.gov Identifier: NCT03202082
Recruitment Status : Unknown
Verified June 2017 by University of South Florida.
Recruitment status was:  Recruiting
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Neuropsychological testing Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: Impact of Neuropsychological Evaluation on Epilepsy Treatment
Actual Study Start Date : July 1, 2015
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Neuropsychological testing
Participants from this group will be administered a neuropsychological battery in addition to the initial and follow-up surveys
Behavioral: Neuropsychological testing
Neuropsychological testing evaluates various aspects of a participants cognitive ability as well as mood.

No Intervention: Treatment as usual
Participants from this group will be administered the initial and follow-up survey.



Primary Outcome Measures :
  1. Epilepsy Outcome Study Survey [ Time Frame: 2-4 months ]
    A brief questionnaire regarding the participants views on their epilepsy treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202082


Locations
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United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Mike R Schoenberg, Ph.D    813-974-8900    mschoenb@health.usf.edu   
Sponsors and Collaborators
University of South Florida

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03202082     History of Changes
Other Study ID Numbers: Satisfaction after Evaluation
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases