Parkinson Disease
Conditions
Brief summary
The purpose of this research study is to determine whether cognitive training will improve cognitive and brain functions in people with Parkinson's Disease (PD) during activities of daily living using cognitive evaluations and magnetic resonance imaging (MRI).
Interventions
BEHAVIORALMental Imagery Training
Participants will practice mental imagery of everyday tasks daily for 6 weeks.
BEHAVIORALPsychoeducation
Participants will receive psychoeducation on cognition and brain health.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic PD * Age ≥ 40 years * Expected to be on a stable dopaminergic medication regimen throughout the study period
Exclusion criteria
* Non-English speaking * Pregnancy * Breastfeeding * Excessive alcohol consumption (\> 7 drinks per week for women, \> 14 drinks per week for men) or illicit substance use * History of a neurological disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, movement disorder (other than PD), or seizures * History of schizophrenia, bipolar disorder, attention deficit disorder, or obsessive-compulsive disorder * History of head injury with loss of consciousness longer than a few minutes * Metallic surgical implants or traumatically implanted metallic foreign bodies * Inability to lie flat for about an hour in the MRI scanner * Discomfort being in small, enclosed spaces * Dementia at screening (Montreal Cognitive Assessment score \< 21/30) * Cognitive problems in activities of daily living suggestive of more than mild cognitive impairment (PD Cognitive Functional Rating Scale \> 4) * Mild cognitive impairment according to the Movement Disorders Society (MDS) Level II comprehensive assessment criteria (\> 1.5 standard deviations below the norm in two tests in a single cognitive domain or in one test in two separate cognitive domains, with the exception that the executive domain scores can be up to 2 standard deviations below the norm) * Hoehn & Yahr stage \> 3 (i.e., able to stand and walk, but not fully independent) * Focal neurological findings on exam that suggest cerebral pathology other than that associated with parkinsonism * Motor symptoms that could potentially introduce too much motion artifact in the imaging data (e.g., MDS-Unified PD Rating Scale resting tremor score \> 2 in limbs, head/chin tremor, or more than mild dyskinesia by history or exam)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks | Baseline and 6 weeks | Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning. |
| Change in Neuro-QoL CF v2 T-scores at 18 Weeks | 18 weeks | Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Executive Function T-scores at 6 Weeks | 6 weeks | T-scores (mean of 50 with a standard deviation of 10) of executive function tests (i.e., Stroop, F-A-S letter fluency, and Trail Making B tests) were averaged to obtain a composite executive function score for each subject. Higher scores indicate better executive function. |
| Change in Composite Executive Function T-scores at 18 Weeks | 18 weeks | T-scores (mean of 50 with a standard deviation of 10) of executive function tests (i.e., Stroop, F-A-S letter fluency, and Trail Making B tests) were averaged to obtain a composite executive function score for each subject. Higher scores indicate better executive function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mental Imagery Participants will practice mental imagery of everyday tasks daily for 6 weeks. | 15 |
| Psychoeducation Participants will receive psychoeducation on cognition and brain health. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Mental Imagery | Total | Psychoeducation |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 8.6 | 67.6 years STANDARD_DEVIATION 8.1 | 67.5 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 28 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 26 Participants | 14 Participants |
| Region of Enrollment United States | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 12 Participants |
| Years of Education | 17.1 years STANDARD_DEVIATION 1.9 | 17.7 years STANDARD_DEVIATION 1.9 | 18.3 years STANDARD_DEVIATION 1.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Neuro-QoL CF v2 T-scores at 18 Weeks
Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.
Time frame: 18 weeks
Population: 15 in the Mental Imagery and 13 in the Psychoeducation group completed 18-week assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Imagery | Change in Neuro-QoL CF v2 T-scores at 18 Weeks | Baseline | 49.9 T-score | Standard Deviation 7.2 |
| Mental Imagery | Change in Neuro-QoL CF v2 T-scores at 18 Weeks | 18 weeks | 49.4 T-score | Standard Deviation 7.4 |
| Psychoeducation | Change in Neuro-QoL CF v2 T-scores at 18 Weeks | Baseline | 49.1 T-score | Standard Deviation 8.4 |
| Psychoeducation | Change in Neuro-QoL CF v2 T-scores at 18 Weeks | 18 weeks | 46.9 T-score | Standard Deviation 6.1 |
Comparison: Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)p-value: 0.993ANCOVA
Primary
Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks
Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.
Time frame: Baseline and 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Imagery | Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks | Baseline | 49.9 T-score | Standard Deviation 7.2 |
| Mental Imagery | Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks | 6 weeks | 50 T-score | Standard Deviation 7.2 |
| Psychoeducation | Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks | Baseline | 49.1 T-score | Standard Deviation 8.4 |
| Psychoeducation | Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks | 6 weeks | 45.9 T-score | Standard Deviation 5.1 |
Comparison: Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)p-value: 0.015ANCOVA
Secondary
Change in Composite Executive Function T-scores at 18 Weeks
T-scores (mean of 50 with a standard deviation of 10) of executive function tests (i.e., Stroop, F-A-S letter fluency, and Trail Making B tests) were averaged to obtain a composite executive function score for each subject. Higher scores indicate better executive function.
Time frame: 18 weeks
Population: 15 in the Mental Imagery group and 13 in the Psychoeducation group completed 18-week assessments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Imagery | Change in Composite Executive Function T-scores at 18 Weeks | Baseline | 53.1 T-score | Standard Deviation 7.9 |
| Mental Imagery | Change in Composite Executive Function T-scores at 18 Weeks | 18 weeks | 55.1 T-score | Standard Deviation 9.6 |
| Psychoeducation | Change in Composite Executive Function T-scores at 18 Weeks | Baseline | 48.7 T-score | Standard Deviation 7.4 |
| Psychoeducation | Change in Composite Executive Function T-scores at 18 Weeks | 18 weeks | 49.5 T-score | Standard Deviation 7.8 |
Comparison: Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)p-value: 0.817ANCOVA
Secondary
Change in Composite Executive Function T-scores at 6 Weeks
T-scores (mean of 50 with a standard deviation of 10) of executive function tests (i.e., Stroop, F-A-S letter fluency, and Trail Making B tests) were averaged to obtain a composite executive function score for each subject. Higher scores indicate better executive function.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mental Imagery | Change in Composite Executive Function T-scores at 6 Weeks | Baseline | 53.1 T-score | Standard Deviation 7.9 |
| Mental Imagery | Change in Composite Executive Function T-scores at 6 Weeks | 6 weeks | 54.7 T-score | Standard Deviation 8.2 |
| Psychoeducation | Change in Composite Executive Function T-scores at 6 Weeks | 6 weeks | 51 T-score | Standard Deviation 9.5 |
| Psychoeducation | Change in Composite Executive Function T-scores at 6 Weeks | Baseline | 48.7 T-score | Standard Deviation 7.4 |
Comparison: Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)p-value: 0.517ANCOVA