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Withdrawn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
About this trial
This is an interventional treatment trial for Parkinson's Disease
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
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
NCT ID
NCT02922530
First Posted
September 29, 2016
Last Updated
February 21, 2017
Sponsor
Posit Science Corporation
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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