Back to resultsComputerized Cognitive Training for Patients With Epilepsy
Primary Purpose
Epilepsy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Luminosity Trial Memory Match
Luminosity Trial Memory Matrix
Luminosity Trial Famliar Faces
Luminosity Trial Brain Shift
Luminosity Trial Star Search
Luminosity Trial Word Bubbles
Luminosity Trial Color Match
Luminosity Trial Ebb and Flow
Luminosity TrialChalk Board Challenge
Luminosiuty Follow that Frog
Luminosity Train of Thought
Sponsored by
About this trial
This is an interventional treatment 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.
- Presence of memory disturbance, as defined by an immediate or delayed memory index score < 85 on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Availability of a home computer and internet for access to the computer training program.
Exclusion Criteria:
- Full Scale IQ < 80, as assessed by an appropriate Wechsler scale (WAIS-IV or WASI-II).
- Epilepsy surgery within 8 weeks of the beginning of the trial.
- History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Alzheimer's disease, multiple sclerosis, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
- History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia or bipolar disorder). 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 or computer training.
- 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.
- Previous exposure (> one week) to Lumosity or a similar computerized training program.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epilepsy Patients
Arm Description
Outcomes
Primary Outcome Measures
Immediate Memory Index Score
Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory
Delayed Memory Index Score
Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03644082
Brief Title
Computerized Cognitive Training for Patients With Epilepsy
Official Title
Computerized Cognitive Training for Patients With Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Problems recruiting and retaining volunteer research personnel to assist with the recruitment of subjects and the study procedures
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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
This is a study on the effectiveness of computerized cognitive training for treatment of memory disorders in patients with epilepsy. Participants will be recruited from patients referred for neuropsychological assessment through the NYU Comprehensive Epilepsy Center's inpatient and outpatient services. Individuals meeting inclusion criteria will be screened for the presence of memory disturbance (defined by results of neuropsychological testing) and lack of exposure to any previous form of computerized cognitive training. All eligible subjects will be provided with an account for Lumosity with instructions to complete training modules 5 days per week for a total of 8 consecutive weeks. Outcomes will be evaluated through changes on the neuropsychological test battery.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epilepsy Patients
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Luminosity Trial Memory Match
Intervention Description
Working memory task that has users indicate whether the current symbol matches the one presented 2 symbols previously. As the user makes correct responses, the previous symbols reduce in contrast and fade int the background, ultimately disappearing, forcing the user to rely entirely on working memory to achieve success
Intervention Type
Behavioral
Intervention Name(s)
Luminosity Trial Memory Matrix
Intervention Description
The purpose id to remember the location of squares on a grid
Intervention Type
Behavioral
Intervention Name(s)
Luminosity Trial Famliar Faces
Intervention Description
The purpose is to create associations between visual and verbal information
Intervention Type
Behavioral
Intervention Name(s)
Luminosity Trial Brain Shift
Intervention Description
The purpose is to decide whether or not cards with numbers and letters are either even or vowels. This measures inhibition, flexibility, and monitoring response set. Also, letterfluency, category fluency, and category switching.
Intervention Type
Behavioral
Intervention Name(s)
Luminosity Trial Star Search
Intervention Description
The purpose is to visually scan several different objects and find the different object in array of pictures. This measures selective attention.
Intervention Type
Behavioral
Intervention Name(s)
Luminosity Trial Word Bubbles
Intervention Description
The purpose is to decide what suffix to use in order to complete a word whena prefix is given. The subject needs to come up with he ending of three different prefixes to complete the word.
This task measures verbal modality, deductive reasoning, integration of multiple bits of information, and flexibility of thinking.
Intervention Type
Behavioral
Intervention Name(s)
Luminosity Trial Color Match
Intervention Description
The purpose is to identify whether colors and words match each other. This measures the ability to inhibit a dominant and automatic verbal response
Intervention Type
Behavioral
Intervention Name(s)
Luminosity Trial Ebb and Flow
Intervention Description
Identify which direction leaves are pointing or moving depending on their color.This measures inhibition of impulsive and perseverative responding, and the ability to establish and maintain instructional set.
Intervention Type
Behavioral
Intervention Name(s)
Luminosity TrialChalk Board Challenge
Intervention Description
purpose is to problem solve quantitative reasoningequationsand to decide which card is greater or if the 2 cards are equal when the math problem is solved.
Intervention Type
Behavioral
Intervention Name(s)
Luminosiuty Follow that Frog
Intervention Description
The purposeis to remember the path a red frog takes as it jump from lilypad to lily pad in a pond. This measures flexibility of thinking on a visual-motor sequencing task and working memory
Intervention Type
Behavioral
Intervention Name(s)
Luminosity Train of Thought
Intervention Description
purpose is to guide specific colored trains into corresponding colored matching houses by attending to the different tracks. This measures divided attention.
Primary Outcome Measure Information:
Title
Immediate Memory Index Score
Description
Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory
Time Frame
12 Months
Title
Delayed Memory Index Score
Description
Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Presence of memory disturbance, as defined by an immediate or delayed memory index score < 85 on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Availability of a home computer and internet for access to the computer training program.
Exclusion Criteria:
Full Scale IQ < 80, as assessed by an appropriate Wechsler scale (WAIS-IV or WASI-II).
Epilepsy surgery within 8 weeks of the beginning of the trial.
History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Alzheimer's disease, multiple sclerosis, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia or bipolar disorder). 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 or computer training.
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.
Previous exposure (> one week) to Lumosity or a similar computerized training program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Barr, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Director
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
Plan to Share IPD
No
Learn more about this trial
Computerized Cognitive Training for Patients With Epilepsy
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