Parkinson's Disease, Mild Cognitive Impairment
Conditions
Keywords
Parkinson's disease, cognition, cognitive training, prospective memory, executive function
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.
Interventions
BEHAVIORALcognitive training
Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
BEHAVIORALactive control cognitive training
The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
BEHAVIORALmemory strategy training
the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
randomized control trial. three arms to the study
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH-EXAMINER) Executive Composite Score | week 0 (before intervention begins), 8 weeks | The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER is used to compute the composite score. -3 and +3 are the minimum and maximum values. Higher scores indicated better performance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive and Memory Strategy Training The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.
cognitive training: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. | 2 |
| Cognitive and Memory Strategy Control Training The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.
cognitive training: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. | 1 |
| Active Control for Cognitive and Memory Strategy Training The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish.
active control cognitive training: The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours.
memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Cognitive and Memory Strategy Training | Cognitive and Memory Strategy Control Training | Active Control for Cognitive and Memory Strategy Training | Total |
|---|---|---|---|---|
| Age, Continuous | 67.5 years | 74 years | 74 years | 72 years |
| Montreal Cognitive Assessment | 25.5 units on a scale | 21 units on a scale | 21 units on a scale | 22 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 2 Participants | 1 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 1 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 3 |
Outcome results
Primary
Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH-EXAMINER) Executive Composite Score
The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER is used to compute the composite score. -3 and +3 are the minimum and maximum values. Higher scores indicated better performance.
Time frame: week 0 (before intervention begins), 8 weeks
Population: Only 4 participants completed the intervention and were assessed at endpoint. NIH-EXAMINER is a computerized assessment and must be completed in person. Due to the COVID-19 pandemic, not all assessments could be done in person. Only 2 participants who completed the intervention were able to be assessed with the NIH-EXAMINER in person. No participants randomized to the the Cognitive and Memory Strategy Control Training completed an endpoint NIH-EXAMINER assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive and Memory Strategy Training | Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH-EXAMINER) Executive Composite Score | 0.34 units on a scale | Standard Error 0 |
| Active Control for Cognitive and Memory Strategy Training | Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH-EXAMINER) Executive Composite Score | -.42 units on a scale | Standard Error 0 |