Early Phase 1
N=54
Cognitive Rehabilitation in Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01085968 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Reaction Time and Variability for Movement Task — 1013.858333; 994.94875; 979.2450877; 910.9120833 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- PC based training (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reaction Time and Variability for Movement Task |
1013.858333; 994.94875; 979.2450877; 910.9120833; 1071.54693; 1069.631 | — |
| SECONDARY Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion |
6.251; 4.897; 6.275; 4.933; 18.853; 14.123 | — |
| SECONDARY Task Errors and Variability |
14.36842105; 6.9; 10; 3.85; 27.21052632; 11.3 | — |
| SECONDARY Functional Dexterity Test (FDT) |
55.048; 41.440; 47.023; 37.627; 54.234; 40.585 | — |
| SECONDARY Symbol Digit Modality Test (SDMT) |
46.842; 49.286; 48.211; 51.000 | — |
Summary
We are testing a computer game-style rehabilitation program for people with Parkinson's disease (PD). People with PD often have difficulty with motor planning, such as initiating or starting movements. We believe that our program will improve performance on a movement initiation task as well as on activities of daily living, such as walking, preparing a meal or opening a medicine bottle. We will measure brain function using functional MRI before and after training to identify brain areas that are involved in improved performance. If effective, computer based training will be an inexpensive treatment for motor planning deficits in PD that is free from side effects and easy to administer to a large number of patients.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of PD dominant on the right side with a Hx of response to dopamine replacement.
Exclusion Criteria
- Contraindication to MRI
- History of stroke or significant head trauma
- Significant vision impairment
- Hx of brain surgery or claustrophobia
- Medication change <4 weeks
- Atypical PD
- Severe tremor
- Presence of motor fluctuations or dyskinesia
- Significantly impaired limb or joint function
- Significant memory impairment
- Depression or daytime sleepiness
Data sourced from ClinicalTrials.gov (NCT01085968). 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.