Cognitive Rehabilitation in PD
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Behavioral: PC based training |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | PC-based Rehabilitation of Motor Planning Deficits in Parkinson Disease |
- Reaction time and variability for movement task [ Time Frame: time of study enrollment, 2 months and 12 months after enrollment ] [ Designated as safety issue: No ]
- functional MRI measured brain activation [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ] [ Designated as safety issue: No ]
- Neuropsychological measures of cognitive function, including reaction time, time to completion and % correct [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 46 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
PD subjects
|
Behavioral: PC based training
Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer.
Other Name: training
|
|
Active Comparator: Arm 2
Age matched controls
|
Behavioral: PC based training
Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer.
Other Name: training
|
Detailed Description:
Our approach is to use PD-based adaptive training to improve performance on IG movement initiation in patients with PD. We have three aims, 1) to systematically evaluate cognitive rehabilitation in people with Parkinson's disease (PD), 2) to examine the neural mechanisms subserving cognitive rehabilitation in PD and 3) to assess the ecological validity of cognitive rehabilitation in PD. We will focus on a single aspect of cognitive function, the decision to initiate a movement. Movements can be internally generated (IG) or externally cued, and motor deficits in PD are typically linked to IG movements. The protocol is designed to drive beneficial neuroplastic changes using a paradigm similar to those that have shown promising results in traumatic brain injury patients. In addition, we will use fMRI to measure activity in underlying basal ganglia-thalamocortical circuits. Finally, because the goal of any research regarding the pathophysiology of disease is to improve the lives of patients with the disease, behavioral and neuropsychological measures will be correlated with fMRI measured functional abnormalities before and after training. Improvement in the initiation of movement has the potential to dramatically improve daily functioning including reducing falls, improving language production and improving proficiency of activities of daily living.
Eligibility| Ages Eligible for Study: | 55 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Elizabeth M Dressler, MA | (530) 754-5022 | elizabeth.dressler@va.gov |
| Contact: Elizabeth A Disbrow, PhD | (916) 366-5340 | Elizabeth.Disbrow@va.gov |
| United States, California | |
| VA Northern California HCS | Recruiting |
| Martinez, California, United States, 94553 | |
| Contact: Elizabeth M Dressler, MA 530-754-5022 elizabeth.dressler@va.gov | |
| Principal Investigator: Elizabeth A Disbrow, PhD | |
| Principal Investigator: | Elizabeth A Disbrow, PhD | VA Northern California HCS |
More Information
Additional Information:
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01085968 History of Changes |
| Other Study ID Numbers: | E7185-R |
| Study First Received: | March 10, 2010 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Parkinson's disease Cognitive deficits fMRI neuro rehabilitation Age Matched Controls |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 23, 2013