Cognitive Rehabilitation in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

PC-based Rehabilitation of Motor Planning Deficits in Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085968
• Other study ID #: E7185-R
• Status: Completed
• Phase: Phase 0
• First received: March 10, 2010
• Last updated: August 28, 2015
• Start date: July 2010
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Overton Brooks VA Medical Center, Shreveport, LA	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Louisiana State University Health Sciences Center Shreveport

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction time and variability for movement task		time of study enrollment, 2 months and 12 months after enrollment	No
Secondary	functional MRI measured brain activation		time of enrollment and 2 months following enrollment (before and after training)	No
Secondary	Neuropsychological measures of cognitive function, including reaction time, time to completion and % correct		time of enrollment and 2 months following enrollment (before and after training)	No