Impact of Individual Cognitive Remediation for Parkinson's Disease

NCT ID: NCT03622840

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2018-10-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Parkinson's disease patients with cognitive impairment

Online cognitive remediation program.

Group Type: OTHER

Cognitive Remediation

Intervention Type: BEHAVIORAL

Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks

Interventions

Cognitive Remediation

Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks

Intervention Type: BEHAVIORAL

Other Intervention Names

Brain.HQ

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anu Raj, Psy.D

Role: PRINCIPAL_INVESTIGATOR

New York Institute of Technology College of Osteopathic Medicine

Locations

New York Institute of Technology College of Osteopathic Medicine

Old Westbury, New York, United States

Countries

United States

Other Identifiers

BHS-1379

Identifier Type: -

Identifier Source: org_study_id