Impact of Individual Cognitive Remediation for Parkinson's Disease

NCT03622840 | Terminated

• 1 other identifier: BHS-1379
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Parkinson Disease

Keywords

Cognitive Remediation

Outcome Measures

Primary Outcomes (1)

• Change of Test of Memory and Learning (TOMAL) score

  Paper based memory and attention test administered at the beginning and end of the study

  Baseline and 11 weeks

Study Arms (1)

Parkinson's disease patients with cognitive impairment

OTHER

Online cognitive remediation program.

Behavioral: Cognitive Remediation

Interventions

Cognitive Remediation BEHAVIORAL

Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks

Also known as: Brain.HQ

Parkinson's disease patients with cognitive impairment

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

New York Institute of Technology College of Osteopathic Medicine

Old Westbury, New York, 11568, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Parkinson Disease

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anu Raj, Psy.D

  New York Institute of Technology College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: August 9, 2018
• Study Start: July 12, 2018
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

US (1)