Clinical trial NCT03622840: Impact of Individual Cognitive Remediation for Parkinson's Disease
Official title: Impact of Individual Cognitive Remediation for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognitive Impairment
Parkinson Disease
Keywords: Cognitive Remediation
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change of Test of Memory and Learning (TOMAL) score
timeFrame: Baseline and 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology College of Osteopathic Medicine
state: New York
Study officials:
affiliation: New York Institute of Technology College of Osteopathic Medicine
name: Anu Raj, Psy.D
role: PRINCIPAL_INVESTIGATOR
References: