NCT02726191

Brief Summary

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.

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 Jan 2017

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withdrawn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

March 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

March 22, 2016

Last Update Submit

July 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Index Score from the Repeatable Battery for the Assessment of Neurocognitive Status (RBANS)

    8 Weeks

Secondary Outcomes (3)

  • The Everyday Cognition Scale (ECog)

    8 Weeks

  • Perceived cognitive abilities on an index of subjective cognitive abilities (Cognitive Self-Report Questionnaire; CSRQ-25)

    8 Weeks

  • Measure of mood (Geriatric Depression Scale)

    8 Weeks

Study Arms (2)

Posit Science

EXPERIMENTAL
Behavioral: Spatial Match ExerciseBehavioral: Temporal Sequence Reconstruction ExerciseBehavioral: Token Task ExerciseBehavioral: Story Recall ExerciseBehavioral: Sample-Match (Within Modality) ExerciseBehavioral: Pair-Match (Across-Modality) ExerciseBehavioral: Triad-FiguresExercise

Lumosity

EXPERIMENTAL
Behavioral: Monster Garden ExerciseBehavioral: Memory Match ExerciseBehavioral: Memory Matrix ExerciseBehavioral: Familiar Faces ExercisesBehavioral: Lost in Migration ExerciseBehavioral: Playing Koi Exercise

Interventions

Posit Science
Posit Science
Posit Science
Posit Science
Lumosity
Lumosity
Lumosity
Lumosity
Lumosity
Lumosity

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
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.
  • Must own a computer or have access to the internet.

You may not qualify if:

  • 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.

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

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stella Karantzoulis, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 1, 2016

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

April 1, 2018

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations