search
Back to results

Impact of Neuropsychological Evaluation on Epilepsy Treatment

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Neuropsychological testing
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Epilepsy

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neuropsychological testing

Treatment as usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Epilepsy Outcome Study Survey
A brief questionnaire regarding the participants views on their epilepsy treatment

Secondary Outcome Measures

Full Information

First Posted
June 26, 2017
Last Updated
June 26, 2017
Sponsor
University of South Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT03202082
Brief Title
Impact of Neuropsychological Evaluation on Epilepsy Treatment
Official Title
Impact of Neuropsychological Evaluation on Epilepsy Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuropsychological testing
Arm Type
Experimental
Arm Description
Participants from this group will be administered a neuropsychological battery in addition to the initial and follow-up surveys
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants from this group will be administered the initial and follow-up survey.
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological testing
Intervention Description
Neuropsychological testing evaluates various aspects of a participants cognitive ability as well as mood.
Primary Outcome Measure Information:
Title
Epilepsy Outcome Study Survey
Description
A brief questionnaire regarding the participants views on their epilepsy treatment
Time Frame
2-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike R Schoenberg, Ph.D
Phone
813-974-8900
Email
mschoenb@health.usf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Neuropsychological Evaluation on Epilepsy Treatment

We'll reach out to this number within 24 hrs