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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Cognitive Remediation Therapy Program (BrainHQ)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11568
      • New York Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects must be currently enrolled in the Rock Steady Boxing Program at the Adele Smithers Parkinson's Disease Center.
2. Subjects must be between 40 and 85 years old (including both ages) at the time of study screening.
3. Subjects must have a diagnosis of Parkinson's disease by a physician.
4. Subjects must have a MOCA score of 20 or above.
5. 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.
6. Subjects must have been clinically stable for 2 weeks prior to consent; in the judgment of the Investigator.
7. Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.
8. Subjects must be technologically capable of utilizing a computer and navigating through the programs.
9. Subjects must be mechanically capable of utilizing a computer and computer mouse.

Exclusion Criteria:

1. Subjects should not be participating in a concurrent research study or other interventional clinical trial 30 days prior to consenting.
2. Subjects should not have a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
3. Subject is unable to physically use a computer or a computer mouse.
4. Subject is unable to or refuses to give consent.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson's Disease Patients receiving Cognitive Remediation Therapy; 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); Brain HQ games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own.
No Intervention: Parkinson's Disease Patients not receiving Cognitive Remediation Therapy; 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?

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.

Collaborators and Investigators

• Sponsor: New York Institute of Technology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: BHS-1660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No