Computerized Cognitive Training in Epilepsy

July 13, 2017 updated by: NYU Langone Health
The purpose of this randomized uncontrolled single-site trial is to evaluate the efficacy of two novel computerized cognitive enhancing software packages for improving cognitive and behavioral outcomes in patients with epilepsy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The proposed investigation will be the first to pit two software packages against each other to evaluate the relative efficacy and feasibility of their use among patients with epilepsy. Pharmacotherapy fails to control seizures in approximately 30% of patients. Use of non-pharmacologic interventions, such as cognitive rehabilitation, has shown some benefit for improving cognitive functions and reducing mood symptoms. Each of the computer exercises employ a set of stimuli that are generalizable and mimic real-world experiences.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • Must own a computer or have access to the internet.

Exclusion Criteria:

  • Full Scale IQ < 80, as assessed by the WASI-II.
  • History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Parkinson's disease, multiple sclerosis, dementia, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
  • History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia). 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Posit Science
Behavioral: Spatial Match Exercise
Behavioral: Temporal Sequence Reconstruction Exercise
Behavioral: Token Task Exercise
Behavioral: Story Recall Exercise
Behavioral: Sample-Match (Within Modality) Exercise
Behavioral: Pair-Match (Across-Modality) Exercise
Behavioral: Triad-FiguresExercise
Experimental: Lumosity
Behavioral: Monster Garden Exercise
Behavioral: Memory Match Exercise
Behavioral: Memory Matrix Exercise
Behavioral: Familiar Faces Exercises
Behavioral: Lost in Migration Exercise
Behavioral: Playing Koi Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Index Score from the Repeatable Battery for the Assessment of Neurocognitive Status (RBANS)
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The Everyday Cognition Scale (ECog)
Time Frame: 8 Weeks
8 Weeks
Perceived cognitive abilities on an index of subjective cognitive abilities (Cognitive Self-Report Questionnaire; CSRQ-25)
Time Frame: 8 Weeks
8 Weeks
Measure of mood (Geriatric Depression Scale)
Time Frame: 8 Weeks
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Stella Karantzoulis, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00398

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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