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

This study has been withdrawn prior to enrollment.
(Principal Investigator departed for another position.)
Sponsor:
Information provided by (Responsible Party):
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT02922530
First received: September 29, 2016
Last updated: February 21, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Parkinson's Disease
Other: Computerized Plasticity-based Adaptive Cognitive Training
Other: Commercially available computerized training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Piloting a Novel, Mobile Cognitive Tracking and Training Tool for Patients With Parkinson's Disease (PD)

Resource links provided by NLM:


Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:
  • Change scores for depressive symptoms using Beck Depression Scale (BDI-II) [ Time Frame: 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 ]

Enrollment: 0
Study Start Date: November 2016
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02922530

Sponsors and Collaborators
Posit Science Corporation
Investigators
Principal Investigator: Alit Stark-Inbar, PhD Posit Science Corporation
Principal Investigator: Mouna Attarha, PhD Posit Science Corporation
  More Information

Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT02922530     History of Changes
Other Study ID Numbers: PSC-1010-16 
Study First Received: September 29, 2016
Last Updated: February 21, 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on February 27, 2017