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Clinical Trials/NCT04955275
NCT04955275
Completed
Not Applicable

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

New York Institute of Technology1 site in 1 country25 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
New York Institute of Technology
Enrollment
25
Locations
1
Primary Endpoint
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
April 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention

Time Frame: Initially, before any intervention/start of study.

A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.

The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Post-Intervention

Time Frame: 10 weeks after intervention/completion of the study.

A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.

Parkinson's Disease Questionnaire (PDQ-39) Pre-Intervention

Time Frame: Initially, before any intervention/start of study.

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.

Parkinson's Disease Questionnaire (PDQ-39) Post-Intervention

Time Frame: 10 weeks after intervention/completion of the study.

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.

Montreal Cognitive Assessment (MOCA) Pre-Intervention Screening

Time Frame: Initially, before any intervention/start of study.

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.

Study Sites (1)

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