Impact of Individual Cognitive Remediation for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Impact of Individual Cognitive Remediation for Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03622840
• Other study ID #: BHS-1379
• Status: Terminated
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: June 2019
• Source: New York Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Parkinson Disease

Intervention

Behavioral:
• Cognitive Remediation
Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks

Locations

Country	Name	City	State
United States	New York Institute of Technology College of Osteopathic Medicine	Old Westbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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