Computerized Cognitive Training for Patients With Epilepsy

Sponsor
NYU Langone Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03644082
Collaborator
(none)
0
1
1
4.9
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Computerized Cognitive Training for Patients With Epilepsy
Anticipated Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Immediate Memory Index Score [12 Months]

    Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory

  2. Delayed Memory Index Score [12 Months]

    Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York University School of Medicine New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03644082
Other Study ID Numbers:
  • 17-01830
First Posted:
Aug 23, 2018
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2021