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Impact of Individual Cognitive Remediation for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03622840
Recruitment Status : Terminated (Completed)
First Posted : August 9, 2018
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cognitive Impairment Parkinson Disease Behavioral: Cognitive Remediation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Individual Cognitive Remediation for Parkinson's Disease
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

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Arms and Interventions
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Arm Intervention/treatment
Parkinson's disease patients with cognitive impairment
Online cognitive remediation program.
 Behavioral: Cognitive Remediation
Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks
Other Name: Brain.HQ


Outcome Measures
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Primary Outcome Measures :
  1. Change of Test of Memory and Learning (TOMAL) score [ Time Frame: Baseline and 11 weeks ]
    Paper based memory and attention test administered at the beginning and end of the study


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622840


Locations
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United States, New York
New York Institute of Technology College of Osteopathic Medicine
Old Westbury, New York, United States, 11568
Sponsors and Collaborators
New York Institute of Technology
Investigators
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Principal Investigator: Anu Raj, Psy.D New York Institute of Technology College of Osteopathic Medicine
More Information
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Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT03622840    
Other Study ID Numbers: BHS-1379
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by New York Institute of Technology:
Cognitive Remediation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases