Computerized Cognitive Training for Patients With Epilepsy

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.

Study Overview

• Status: Withdrawn
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Luminosity Trial Memory Match; Behavioral: Luminosity Trial Memory Matrix; Behavioral: Luminosity Trial Famliar Faces; Behavioral: Luminosity Trial Brain Shift; Behavioral: Luminosity Trial Star Search; Behavioral: Luminosity Trial Word Bubbles; Behavioral: Luminosity Trial Color Match; Behavioral: Luminosity Trial Ebb and Flow; Behavioral: Luminosity TrialChalk Board Challenge; Behavioral: Luminosiuty Follow that Frog; Behavioral: Luminosity Train of Thought

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Epilepsy Patients

Behavioral: Luminosity Trial Memory Match; 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; Behavioral: Luminosity Trial Memory Matrix; The purpose id to remember the location of squares on a grid; Behavioral: Luminosity Trial Famliar Faces; The purpose is to create associations between visual and verbal information; Behavioral: Luminosity Trial Brain Shift; 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.; Behavioral: Luminosity Trial Star Search; The purpose is to visually scan several different objects and find the different object in array of pictures. This measures selective attention.; Behavioral: Luminosity Trial Word Bubbles; 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.; Behavioral: Luminosity Trial Color Match; The purpose is to identify whether colors and words match each other. This measures the ability to inhibit a dominant and automatic verbal response; Behavioral: Luminosity Trial Ebb and Flow; 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.; Behavioral: Luminosity TrialChalk Board Challenge; 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.; Behavioral: Luminosiuty Follow that Frog; 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; Behavioral: Luminosity Train of Thought; purpose is to guide specific colored trains into corresponding colored matching houses by attending to the different tracks. This measures divided attention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate Memory Index Score	Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory	12 Months
Delayed Memory Index Score	Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory	12 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Study Director: William Barr, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 17-01830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No