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OpenTrials
Completed

NCT Number: NCT04955275

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Institute of Technology

Old Westbury, New York, 11568, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Remediation Therapy Program (BrainHQ)

Other

Brain HQ games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2021
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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