Back to resultsThe Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation Therapy Program (BrainHQ)
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson Disease
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.
Sites / Locations
- New York Institute of Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Parkinson's Disease Patients receiving Cognitive Remediation Therapy
Parkinson's Disease Patients not receiving Cognitive Remediation Therapy
Arm Description
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.
Parkinson's Disease Subjects will receive no intervention, but still undergo pre- and post-intervention RBANS and PDQ-39 scores.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04955275
First Posted
June 17, 2021
Last Updated
October 3, 2022
Sponsor
New York Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT04955275
Brief Title
The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
Official Title
The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's Disease Patients receiving Cognitive Remediation Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Parkinson's Disease Patients not receiving Cognitive Remediation Therapy
Arm Type
No Intervention
Arm Description
Parkinson's Disease Subjects will receive no intervention, but still undergo pre- and post-intervention RBANS and PDQ-39 scores.
Intervention Type
Other
Intervention Name(s)
Cognitive Remediation Therapy Program (BrainHQ)
Intervention Description
Brain HQ games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own.
Primary Outcome Measure Information:
Title
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention
Description
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Time Frame
Initially, before any intervention/start of study.
Title
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Post-Intervention
Description
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Time Frame
10 weeks after intervention/completion of the study.
Title
Parkinson's Disease Questionnaire (PDQ-39) Pre-Intervention
Description
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.
Time Frame
Initially, before any intervention/start of study.
Title
Parkinson's Disease Questionnaire (PDQ-39) Post-Intervention
Description
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.
Time Frame
10 weeks after intervention/completion of the study.
Title
Montreal Cognitive Assessment (MOCA) Pre-Intervention Screening
Description
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.
Time Frame
Initially, before any intervention/start of study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
New York Institute of Technology
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29557365
Citation
Diez-Cirarda M, Ibarretxe-Bilbao N, Pena J, Ojeda N. Efficacy of cognitive rehabilitation in Parkinson's disease. Neural Regen Res. 2018 Feb;13(2):226-227. doi: 10.4103/1673-5374.226390. No abstract available.
Results Reference
background
PubMed Identifier
27757820
Citation
Diez-Cirarda M, Ojeda N, Pena J, Cabrera-Zubizarreta A, Lucas-Jimenez O, Gomez-Esteban JC, Gomez-Beldarrain MA, Ibarretxe-Bilbao N. Increased brain connectivity and activation after cognitive rehabilitation in Parkinson's disease: a randomized controlled trial. Brain Imaging Behav. 2017 Dec;11(6):1640-1651. doi: 10.1007/s11682-016-9639-x.
Results Reference
background
PubMed Identifier
24605806
Citation
Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
Results Reference
background
PubMed Identifier
32092069
Citation
Gough N, Brkan L, Subramaniam P, Chiuccariello L, De Petrillo A, Mulsant BH, Bowie CR, Rajji TK. Feasibility of remotely supervised transcranial direct current stimulation and cognitive remediation: A systematic review. PLoS One. 2020 Feb 24;15(2):e0223029. doi: 10.1371/journal.pone.0223029. eCollection 2020.
Results Reference
background
PubMed Identifier
24322063
Citation
Milman U, Atias H, Weiss A, Mirelman A, Hausdorff JM. Can cognitive remediation improve mobility in patients with Parkinson's disease? Findings from a 12 week pilot study. J Parkinsons Dis. 2014;4(1):37-44. doi: 10.3233/JPD-130321.
Results Reference
background
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The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
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