Cognitive Rehabilitation in Parkinson's Disease

VA Office of Research and Development

Status and phase: Completed; Early Phase 1

Conditions: Parkinson's Disease

Treatments: Behavioral: PC based training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01085968

E7185-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

PD Subjects

Experimental group

Description:

PD subjects who undergo to PC-based neurorehabilitation intervention. This intervention will train research subjects to improve movement initiation in response to visual stimuli.

Treatment:

Behavioral: PC based training

Control Subjects

Active Comparator group

Description:

Age matched controls who undergo to PC-based neurorehabilitation intervention. This intervention will train research subjects to improve movement initiation in response to visual stimuli.

Treatment:

Behavioral: PC based training