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Impact of Individual Cognitive Remediation for Parkinson's Disease

Primary Purpose

Cognitive Impairment, Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Impairment focused on measuring Cognitive Remediation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects must be between 40 and 75 years old (including both ages) at the time of study screening.
  2. Subjects must have a diagnosis of Parkinson's Disease by a physician.
  3. 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.
  4. Subjects must have been clinically stable (non-acute) for 2 weeks prior to consent; in the judgment of the Investigator.
  5. Subjects with a cognition level between Impaired and Average (scaled score between 4-12 or Index Score between 70-110) based on TOMAL Cognitive assessment at Visit 1
  6. Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.

Exclusion Criteria:

  1. Subjects who are participating in a concurrent research study or another interventional clinical trial 30 days prior to consenting.
  2. Subjects having a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
  3. Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled and may be discontinued based upon the discretion of the investigator
  4. Subjects on medications that affect the cognition in the last 12 hours prior to the study visits that assess the cognitive functions

Sites / Locations

  • New York Institute of Technology College of Osteopathic Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Parkinson's disease patients with cognitive impairment

Arm Description

Online cognitive remediation program.

Outcomes

Primary Outcome Measures

Change of Test of Memory and Learning (TOMAL) score
Paper based memory and attention test administered at the beginning and end of the study

Secondary Outcome Measures

Full Information

First Posted
June 20, 2018
Last Updated
June 18, 2019
Sponsor
New York Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03622840
Brief Title
Impact of Individual Cognitive Remediation for Parkinson's Disease
Official Title
Impact of Individual Cognitive Remediation for Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an interventional clinical trial that will be conducted as a pilot project. Investigators hope to conduct the study to obtain at least 10 study completers. The plan is to screen 20 Parkinson's Disease (PD) patients attending the Academic Health Care Center (AHCC) at NYIT College of Osteopathic Medicine clinic and enroll the eligible candidates based on the inclusion and exclusion criteria. Subjects will have 11 study visits over the 11-week period. Subjects cognition will be assessed using a paper-based Test of Memory and Learning (TOMAL) tool. The same tool will be used to asses and compare the cognition at baseline, and end study visits. The weekly 30-mins of cognitive remediation exercises will be done using the Brain. HQ cognitive remediation software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Parkinson Disease
Keywords
Cognitive Remediation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's disease patients with cognitive impairment
Arm Type
Other
Arm Description
Online cognitive remediation program.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Other Intervention Name(s)
Brain.HQ
Intervention Description
Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks
Primary Outcome Measure Information:
Title
Change of Test of Memory and Learning (TOMAL) score
Description
Paper based memory and attention test administered at the beginning and end of the study
Time Frame
Baseline and 11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must be between 40 and 75 years old (including both ages) at the time of study screening. Subjects must have a diagnosis of Parkinson's Disease by a physician. 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. Subjects must have been clinically stable (non-acute) for 2 weeks prior to consent; in the judgment of the Investigator. Subjects with a cognition level between Impaired and Average (scaled score between 4-12 or Index Score between 70-110) based on TOMAL Cognitive assessment at Visit 1 Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator. Exclusion Criteria: Subjects who are participating in a concurrent research study or another interventional clinical trial 30 days prior to consenting. Subjects having a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.) Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled and may be discontinued based upon the discretion of the investigator Subjects on medications that affect the cognition in the last 12 hours prior to the study visits that assess the cognitive functions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anu Raj, Psy.D
Organizational Affiliation
New York Institute of Technology College of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Institute of Technology College of Osteopathic Medicine
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Impact of Individual Cognitive Remediation for Parkinson's Disease

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