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

Sponsor
New York Institute of Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT04955275
Collaborator
(none)
26
1
2
14
1.9

Study Details

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 AHCC 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive Remediation Therapy Program (BrainHQ)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 16, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York Institute of Technology Old Westbury New York United States 11568

Sponsors and Collaborators

  • New York Institute of Technology

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
New York Institute of Technology
ClinicalTrials.gov Identifier:
NCT04955275
Other Study ID Numbers:
  • BHS-1660
First Posted:
Jul 8, 2021
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022