Clinical trial NCT04955275: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention
timeFrame: Initially, before any intervention/start of study.
measure: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Post-Intervention
timeFrame: 10 weeks after intervention/completion of the study.
measure: Parkinson's Disease Questionnaire (PDQ-39) Pre-Intervention
timeFrame: Initially, before any intervention/start of study.
measure: Parkinson's Disease Questionnaire (PDQ-39) Post-Intervention
timeFrame: 10 weeks after intervention/completion of the study.
measure: Montreal Cognitive Assessment (MOCA) Pre-Intervention Screening
timeFrame: Initially, before any intervention/start of study.
Secondary outcomes:
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology
state: New York
Study officials:
References:
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.
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.
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.
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.
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.