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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Cognitive Remediation Therapy Program (BrainHQ)

• Registration Number: NCT04955275
• Lead Sponsor: New York Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-07-08
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parkinson's Disease Patients receiving Cognitive Remediation Therapy	Cognitive Remediation Therapy Program (BrainHQ)	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.

Primary Outcome Measures

Name	Time	Method
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention	Initially, before any intervention/start of study.	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	10 weeks after intervention/completion of the study.	A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Parkinson's Disease Questionnaire (PDQ-39) Pre-Intervention	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.
Parkinson's Disease Questionnaire (PDQ-39) Post-Intervention	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.
Montreal Cognitive Assessment (MOCA) Pre-Intervention Screening	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.

Trial Locations

Locations (1)

New York Institute of Technology; 🇺🇸 Old Westbury, New York, United States