Clinical trial NCT01085968: Cognitive Rehabilitation in Parkinson's Disease
Official title: PC-based Rehabilitation of Motor Planning Deficits in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Cognitive deficits
fMRI
neuro rehabilitation
Age Matched Controls
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Louisiana State University Health Sciences Center Shreveport
First posted: 2010-03-12
Enrollment: 54
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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

Primary outcomes:
measure: Reaction Time and Variability for Movement Task
timeFrame: time of enrollment and 2 months following enrollment (before and after training)
Secondary outcomes:
measure: Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
timeFrame: time of enrollment and 2 months following enrollment (before and after training)
measure: Task Errors and Variability
timeFrame: time of enrollment and 2 months following enrollment (before and after training)
measure: Functional Dexterity Test (FDT)
timeFrame: time of enrollment and 2 months following enrollment (before and after training)
measure: Symbol Digit Modality Test (SDMT)
timeFrame: time of enrollment and 2 months following enrollment (before and after training)
Other outcomes:
Locations:
Study officials:
affiliation: Overton Brooks VA Medical Center, Shreveport, LA
name: Elizabeth A Disbrow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Disbrow EA, Russo KA, Higginson CI, Yund EW, Ventura MI, Zhang L, Malhado-Chang N, Woods DL, Sigvardt KA. Efficacy of tailored computer-based neurorehabilitation for improvement of movement initiation in Parkinson's disease. Brain Res. 2012 May 3;1452:151-64. doi: 10.1016/j.brainres.2012.02.073. Epub 2012 Mar 9.