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

February 21, 2017 updated by: Posit Science Corporation
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Treatment
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
Other: Computerized Plasticity-based Adaptive Cognitive Training
Active Comparator: Active Comparator
Commercially available computerized training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session.
Other: Commercially available computerized training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change scores for depressive symptoms using Beck Depression Scale (BDI-II)
Time Frame: At 3 months and 6 months
At 3 months and 6 months
Change scores for Quality of Life using Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: At 3 months and 6 months
At 3 months and 6 months

Collaborators and Investigators

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

Sponsor

Posit Science Corporation

Investigators

  • Principal Investigator: Alit Stark-Inbar, PhD, Posit Science Corporation
  • Principal Investigator: Mouna Attarha, PhD, Posit Science Corporation

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

November 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSC-1010-16

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.

Subscribe