Clinical trial NCT03836963: Cognitive Rehab for Parkinson's
Official title: Cognitive Rehabilitation for Veterans With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Mild Cognitive Impairment
Keywords: Parkinson's disease
cognition
cognitive training
prospective memory
executive function
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-02-11
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial. three arms to the study
Primary purpose: TREATMENT

Brief summary: This study will examine the feasibility of an at-home cognitive training program that incorporates both memory training and online computerized cognitive training (CCT) software. Data will also be collected to determine if this program improves thinking and memory as well as everyday function. The hypothesis is that memory and cognitive training combined , compared to memory training alone or will lead to greater improvements in cognitive performance and daily function.

Detailed description: The objective of this study is to examine feasibility of an at-home cognitive rehabilitation program that incorporates both prospective implementation intentions strategies (PRIIS) and an existing web-based executive function (EF) computerized cognitive training (CCT) software for Veterans with Parkinson's disease (PD) and to collect pilot data to determine the impact of this program on cognition and everyday function. The central hypothesis is that CCT+PRIIS, compared to CCT alone and an active control group, will lead to greater improvements in cognitive performance and daily function. This innovative study uses a set of on-line training games that target aspects of EF susceptible in PD and trains the transfer of cognitive benefits to everyday function, using PRIIS, for Veterans with PD and mild cognitive impairment in executive function. Additionally, training is conducted at home allowing for convenience and flexibility for participants.

Eligibility criteria: Inclusion Criteria:

* Veterans who seek services at Hines VA Hospital
* Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
* Meet criteria for having mild cognitive impairment
* Receiving stable (i.e., no changes in medication and medication dose) medication and who are expected to remain on stable medication for the duration of the RCT
* 50 years or older
* Speak and read English

Exclusion Criteria:

* Dementia
* Failure to demonstrate decision making capacity
* Cholinesterase inhibitor medication
* History of deep brain stimulation surgery
* Severe depression
* Severe anxiety
* Severe apathy

Primary outcomes:
measure: Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH-EXAMINER) Executive Composite Score
timeFrame: week 0 (before intervention begins), 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Sandra L. Kletzel, PhD BA
role: PRINCIPAL_INVESTIGATOR
References: