Back to resultsComputerized Cognitive Training in Epilepsy
Primary Purpose
Epilepsy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spatial Match Exercise
Temporal Sequence Reconstruction Exercise
Token Task Exercise
Story Recall Exercise
Sample-Match (Within Modality) Exercise
Pair-Match (Across-Modality) Exercise
Triad-FiguresExercise
Monster Garden Exercise
Memory Match Exercise
Memory Matrix Exercise
Familiar Faces Exercises
Lost in Migration Exercise
Playing Koi Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of epilepsy based on medical records. The records will be reviewed by the PI and the approved study personnel to confirm that a diagnosis of epilepsy has been made.
- Must own a computer or have access to the internet.
Exclusion Criteria:
- Full Scale IQ < 80, as assessed by the WASI-II.
- History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Parkinson's disease, multiple sclerosis, dementia, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
- History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia). Patients with depression or anxiety (treated or untreated) without psychotic features are not excluded.
- Visual or auditory impairment, which precludes participation in part, or all of the testing.
- English as a first language will not be required, but participants must have either received some of their schooling in English or used English in their work for >10 years.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Posit Science
Lumosity
Arm Description
Outcomes
Primary Outcome Measures
Total Index Score from the Repeatable Battery for the Assessment of Neurocognitive Status (RBANS)
Secondary Outcome Measures
The Everyday Cognition Scale (ECog)
Perceived cognitive abilities on an index of subjective cognitive abilities (Cognitive Self-Report Questionnaire; CSRQ-25)
Measure of mood (Geriatric Depression Scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02726191
Brief Title
Computerized Cognitive Training in Epilepsy
Official Title
Computerized Cognitive Training in Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study Lapsed
Study Start Date
January 2017 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this randomized uncontrolled single-site trial is to evaluate the efficacy of two novel computerized cognitive enhancing software packages for improving cognitive and behavioral outcomes in patients with epilepsy.
Detailed Description
The proposed investigation will be the first to pit two software packages against each other to evaluate the relative efficacy and feasibility of their use among patients with epilepsy. Pharmacotherapy fails to control seizures in approximately 30% of patients. Use of non-pharmacologic interventions, such as cognitive rehabilitation, has shown some benefit for improving cognitive functions and reducing mood symptoms. Each of the computer exercises employ a set of stimuli that are generalizable and mimic real-world experiences.
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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posit Science
Arm Type
Experimental
Arm Title
Lumosity
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Spatial Match Exercise
Intervention Type
Behavioral
Intervention Name(s)
Temporal Sequence Reconstruction Exercise
Intervention Type
Behavioral
Intervention Name(s)
Token Task Exercise
Intervention Type
Behavioral
Intervention Name(s)
Story Recall Exercise
Intervention Type
Behavioral
Intervention Name(s)
Sample-Match (Within Modality) Exercise
Intervention Type
Behavioral
Intervention Name(s)
Pair-Match (Across-Modality) Exercise
Intervention Type
Behavioral
Intervention Name(s)
Triad-FiguresExercise
Intervention Type
Behavioral
Intervention Name(s)
Monster Garden Exercise
Intervention Type
Behavioral
Intervention Name(s)
Memory Match Exercise
Intervention Type
Behavioral
Intervention Name(s)
Memory Matrix Exercise
Intervention Type
Behavioral
Intervention Name(s)
Familiar Faces Exercises
Intervention Type
Behavioral
Intervention Name(s)
Lost in Migration Exercise
Intervention Type
Behavioral
Intervention Name(s)
Playing Koi Exercise
Primary Outcome Measure Information:
Title
Total Index Score from the Repeatable Battery for the Assessment of Neurocognitive Status (RBANS)
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
The Everyday Cognition Scale (ECog)
Time Frame
8 Weeks
Title
Perceived cognitive abilities on an index of subjective cognitive abilities (Cognitive Self-Report Questionnaire; CSRQ-25)
Time Frame
8 Weeks
Title
Measure of mood (Geriatric Depression Scale)
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Documented diagnosis of epilepsy based on medical records. The records will be reviewed by the PI and the approved study personnel to confirm that a diagnosis of epilepsy has been made.
Must own a computer or have access to the internet.
Exclusion Criteria:
Full Scale IQ < 80, as assessed by the WASI-II.
History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Parkinson's disease, multiple sclerosis, dementia, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia). Patients with depression or anxiety (treated or untreated) without psychotic features are not excluded.
Visual or auditory impairment, which precludes participation in part, or all of the testing.
English as a first language will not be required, but participants must have either received some of their schooling in English or used English in their work for >10 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stella Karantzoulis, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computerized Cognitive Training in Epilepsy
We'll reach out to this number within 24 hrs