N/A
N=30
Cognitive Training in Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT05495997 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks — 49.9; 49.1; 50; 45.9 T-score — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mental Imagery Training (Behavioral); Psychoeducation (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks |
49.9; 49.1; 50; 45.9 | 0.015 sig |
| PRIMARY Change in Neuro-QoL CF v2 T-scores at 18 Weeks |
49.9; 49.1; 49.4; 46.9 | 0.993 |
| SECONDARY Change in Composite Executive Function T-scores at 6 Weeks |
53.1; 48.7; 54.7; 51 | 0.517 |
| SECONDARY Change in Composite Executive Function T-scores at 18 Weeks |
53.1; 48.7; 55.1; 49.5 | 0.817 |
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).
Eligibility Criteria
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 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)
Data sourced from ClinicalTrials.gov (NCT05495997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.