NCT03644082

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

August 21, 2018

Last Update Submit

June 29, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Epilepsy Patients

EXPERIMENTAL
Behavioral: Luminosity Trial Memory MatchBehavioral: Luminosity Trial Memory MatrixBehavioral: Luminosity Trial Famliar FacesBehavioral: Luminosity Trial Brain ShiftBehavioral: Luminosity Trial Star SearchBehavioral: Luminosity Trial Word BubblesBehavioral: Luminosity Trial Color MatchBehavioral: Luminosity Trial Ebb and FlowBehavioral: Luminosity TrialChalk Board ChallengeBehavioral: Luminosiuty Follow that FrogBehavioral: Luminosity Train of Thought

Interventions

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

Epilepsy Patients

The purpose id to remember the location of squares on a grid

Epilepsy Patients

The purpose is to create associations between visual and verbal information

Epilepsy Patients

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.

Epilepsy Patients

The purpose is to visually scan several different objects and find the different object in array of pictures. This measures selective attention.

Epilepsy Patients

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.

Epilepsy Patients

The purpose is to identify whether colors and words match each other. This measures the ability to inhibit a dominant and automatic verbal response

Epilepsy Patients

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.

Epilepsy Patients

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.

Epilepsy Patients

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

Epilepsy Patients

purpose is to guide specific colored trains into corresponding colored matching houses by attending to the different tracks. This measures divided attention.

Epilepsy Patients

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • William Barr, MD

    NYU Langone Health

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 23, 2018

Study Start

December 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations