The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease

Study Overview
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Brief Summary
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Purpose/Goal: To determine if a remote computerized cognitive remediation program (CRT) can stabilize or improve cognitive functioning in a group of patients from the New York Institute of Technology Academic Health Care Center with Parkinson's disease (PD) after three months of intervention. Hypothesis: Patients with PD who present with current cognitive deficits will show improvement in such deficits after three months of participation in a remotely supervised structured Cognitive Remediation Therapy Program (CRT) compared to control subjects with PD who receive treatment as usual. Research design: Pilot study. Prospective randomized treatment and control comparison pre-post study.

Official Title
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The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Cognitive Remediation Therapy Program (BrainHQ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be currently enrolled in the Rock Steady Boxing Program at the Adele Smithers Parkinson's Disease Center. Subjects must be between 40 and 85 years old (including both ages) at the time of study screening. Subjects must have a diagnosis of Parkinson's disease by a physician. Subjects must have a MOCA score of 20 or above. Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study. Subjects must have been clinically stable for 2 weeks prior to consent; in the judgment of the Investigator. Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator. Subjects must be technologically capable of utilizing a computer and navigating through the programs. Subjects must be mechanically capable of utilizing a computer and computer mouse. Exclusion Criteria: Subjects should not be participating in a concurrent research study or other interventional clinical trial 30 days prior to consenting. Subjects should not have a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.) Subject is unable to physically use a computer or a computer mouse. Subject is unable to or refuses to give consent.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson's Disease Patients receiving Cognitive Remediation Therapy<br>Parkinson's Disease Subjects will undergo 10 weeks of Brain HQ training, 2 times a week an hour at a time. Also patients pre- and post-intervention RBANS and PDQ-39 scores. | Other: Cognitive Remediation Therapy Program (BrainHQ)<br>* Brain HQ games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own.<br>|
| No Intervention: Parkinson's Disease Patients not receiving Cognitive Remediation Therapy<br>Parkinson's Disease Subjects will receive no intervention, but still undergo pre- and post-intervention RBANS and PDQ-39 scores. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention | A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. | Initially, before any intervention/start of study. | 
| The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Post-Intervention | A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. | 10 weeks after intervention/completion of the study. | 
| Parkinson's Disease Questionnaire (PDQ-39) Pre-Intervention | A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. | Initially, before any intervention/start of study. | 
| Parkinson's Disease Questionnaire (PDQ-39) Post-Intervention | A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. | 10 weeks after intervention/completion of the study. | 
| Montreal Cognitive Assessment (MOCA) Pre-Intervention Screening | A rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. | Initially, before any intervention/start of study. |