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Piloting a Novel, Mobile Cognitive Tracking and Training Tool for Patients With Parkinson's Disease (PD)

Primary Purpose

Parkinson's Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computerized Plasticity-based Adaptive Cognitive Training
Commercially available computerized training
Sponsored by
Posit Science Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants must meet diagnostic criteria for Parkinson's Disease with mild-to-moderate stage
  • Participants must be fluent English speakers
  • Participants must have the capability of completing the study as assessed by intact global cognition
  • Participants must be able to engage with computerized cognitive tasks as required in the study
  • Participants must have normal vision (or corrected to normal vision)
  • Participants must have adequate hearing acuity
  • Participants must have the motor capacity to use an iPad or mobile device
  • Participants must be willing to commit to the time requirements of the study
  • Participants must obtain benefit on dopaminergic treatment (dopamine agonist or levodopa) and be on a stable dose for at least one month prior to screening
  • Participant must have access to wireless internet connectivity
  • Participant must have at least mild depression as assessed by Beck Depression Inventory (BDI-II)

Exclusion Criteria:

  • Participants who are unable to perform neuropsychological assessments in the opinion of the evaluating staff person
  • Participants who cannot comprehend or follow instructions, in the opinion of the consenting staff person
  • Participants who are not capable of giving informed consent, in the opinion of the consenting staff person
  • Participants who show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
  • Participants with history of significant medical diseases or multiple neurological events of the head
  • Participants with serious or unstable medical illness
  • Participants with history or current diagnosis of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-5) psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specific, bipolar disorder, substance dependence, substance abuse (< 1 year) (subjects with co-occurring post-traumatic stress disorder and related disorders are eligible for participation) as diagnosed through medical history
  • Participants with history of seizure disorder
  • Participants who are pregnant
  • Participants who experience frequent falls (several times a week)
  • Participants with severe dyskinesia
  • Participants with active suicidal ideations or behaviors as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study
  • Participant is using computer-based cognitive training programs or has used it within a month of the consent date

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental Treatment

    Active Comparator

    Arm Description

    Computerized plasticity-based adaptive cognitive training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session

    Commercially available computerized training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session.

    Outcomes

    Primary Outcome Measures

    Change scores for depressive symptoms using Beck Depression Scale (BDI-II)
    Change scores for Quality of Life using Parkinson's Disease Questionnaire (PDQ-39)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2016
    Last Updated
    February 21, 2017
    Sponsor
    Posit Science Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02922530
    Brief Title
    Piloting a Novel, Mobile Cognitive Tracking and Training Tool for Patients With Parkinson's Disease (PD)
    Official Title
    Piloting a Novel, Mobile Cognitive Tracking and Training Tool for Patients With Parkinson's Disease (PD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Principal Investigator departed for another position.
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Posit Science Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    The overall goal of this research proposal is to develop an adjunct to standard treatments that 'correct' disrupted neural circuitry in Parkinson's Disease (PD) patients. Directly treating these core deficits via targeted behavioral training should slow the progression of PD, assure greater resilience against future decline, and improve the quality of life of many living with PD. The purpose of this exploratory research study is to determine the benefits, if any, of the mobile device-based treatment described above in individuals with PD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Treatment
    Arm Type
    Experimental
    Arm Description
    Computerized plasticity-based adaptive cognitive training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session
    Arm Title
    Active Comparator
    Arm Type
    Active Comparator
    Arm Description
    Commercially available computerized training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session.
    Intervention Type
    Other
    Intervention Name(s)
    Computerized Plasticity-based Adaptive Cognitive Training
    Intervention Type
    Other
    Intervention Name(s)
    Commercially available computerized training
    Primary Outcome Measure Information:
    Title
    Change scores for depressive symptoms using Beck Depression Scale (BDI-II)
    Time Frame
    At 3 months and 6 months
    Title
    Change scores for Quality of Life using Parkinson's Disease Questionnaire (PDQ-39)
    Time Frame
    At 3 months and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants must meet diagnostic criteria for Parkinson's Disease with mild-to-moderate stage Participants must be fluent English speakers Participants must have the capability of completing the study as assessed by intact global cognition Participants must be able to engage with computerized cognitive tasks as required in the study Participants must have normal vision (or corrected to normal vision) Participants must have adequate hearing acuity Participants must have the motor capacity to use an iPad or mobile device Participants must be willing to commit to the time requirements of the study Participants must obtain benefit on dopaminergic treatment (dopamine agonist or levodopa) and be on a stable dose for at least one month prior to screening Participant must have access to wireless internet connectivity Participant must have at least mild depression as assessed by Beck Depression Inventory (BDI-II) Exclusion Criteria: Participants who are unable to perform neuropsychological assessments in the opinion of the evaluating staff person Participants who cannot comprehend or follow instructions, in the opinion of the consenting staff person Participants who are not capable of giving informed consent, in the opinion of the consenting staff person Participants who show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit Participants with history of significant medical diseases or multiple neurological events of the head Participants with serious or unstable medical illness Participants with history or current diagnosis of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-5) psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specific, bipolar disorder, substance dependence, substance abuse (< 1 year) (subjects with co-occurring post-traumatic stress disorder and related disorders are eligible for participation) as diagnosed through medical history Participants with history of seizure disorder Participants who are pregnant Participants who experience frequent falls (several times a week) Participants with severe dyskinesia Participants with active suicidal ideations or behaviors as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study Participant is using computer-based cognitive training programs or has used it within a month of the consent date
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alit Stark-Inbar, PhD
    Organizational Affiliation
    Posit Science Corporation
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mouna Attarha, PhD
    Organizational Affiliation
    Posit Science Corporation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Piloting a Novel, Mobile Cognitive Tracking and Training Tool for Patients With Parkinson's Disease (PD)

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