Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Computerized Cognitive Training for Patients With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03644082
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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
Epilepsy 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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computerized Cognitive Training for Patients With Epilepsy
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Memory

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.




Primary Outcome Measures :
  1. Immediate Memory Index Score [ Time Frame: 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 [ Time Frame: 12 Months ]
    Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644082


Contacts
Layout table for location contacts
Contact: Kayla Whearty 646 558 0809 Kayla.Whearty@nyumc.org

Locations
Layout table for location information
United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Kayla Whearty    646-558-0809    kayla.wheart@nyumc.org   
Principal Investigator: William Barr, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Layout table for investigator information
Study Director: William Barr, MD New York University School of Medicine

Layout table for additonal information
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03644082     History of Changes
Other Study ID Numbers: 17-01830
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases