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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04955275
• Other study ID #: BHS-1660
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: October 2022
• Source: New York Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	New York Institute of Technology	Old Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

References & Publications (5)

Díez-Cirarda M, Ibarretxe-Bilbao N, Peña 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. — View Citation

Díez-Cirarda M, Ojeda N, Peña J, Cabrera-Zubizarreta A, Lucas-Jiménez O, Gómez-Esteban JC, Gómez-Beldarrain MÁ, 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.