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Official Study Title: PC-Based Rehabilitation of Motor Planning Deficits in Parkinson Disease
Sponsor: Department of Veterans Affairs, University of California, Davis
Clinicaltrials.gov ID: NCT01085968
Study ID: E7185R

Summary

People with Parkinson’s disease (PD) often have difficulty with motor planning, such as initiating or starting movements. To investigate effective methods of addressing such symptoms, this study will test a computer game-style rehabilitation program for people with PD. The investigator believes that the 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.

Brain function will be measured 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  Side Effects Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include such symptoms as headache, nausea and upset stomach. In some cases, side-effects may cause more severe medical problems. and easy to administer to a large number of patients.
 
This study will measure the effectiveness  EffectivenessAbility of a drug or treatment to produce a result. of the computer-style rehabilitation program on the reaction time and variability of movement tasks.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Movement Symptoms

Loss of Motor Skills, Walking/Gait  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms.

Time Commitment

• More than six months
• Volunteers will be asked to undergo a brain scan (about two hours) and some paper and pencil tests (about two hours on another day). The training program takes about 40 minutes per day and should be done for up to 30 days. Volunteers will then be scanned and tested again. Finally, volunteers will receive the paper and pencil tests one more time one year after enrollment.

Eligibility

• Minimum Age: 55
• Maximum Age: 75
• Gender(s) Accepted: Either
• Study is enrolling non-PD participants

Inclusion Criteria

• Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. diagnosis of PD dominant on the right side

Exclusion Criteria

• History of stroke or significant head trauma
• Significant vision impairment
• Medication change within the past four weeks (investigators can schedule around recent changes)
• Severe tremors
• Presence of motor fluctuations or uncontrollable, jerky movements (dyskinesia)  DyskinesiaTwisting, turning or other abnormal involuntary movement usually involving the arms, legs, trunk, and head. It is most commonly associated with long-term use of levodopa.
• Significantly impaired limb or joint function
• Significant memory impairment, depression or daytime sleepiness

Enrollment

Expected Enrollment: 46 (US)
Date Enrollment Began: Apr 2010
Date Enrollment Ends: Aug 2012
Last Updated Date: Apr 12 2010
Trial Post Date: Apr 12 2010
Website: http://clinicaltrials.gov/ct2/show/NCT01085968?recr=Open&cond=parkinson&rcv_d=14

Primary Contacts and Locations

California

• Becky Stein
  University of California, Davis
  rlstein89@gmail.com
  Phone: (530) 754-5022
  1544 Newton Ct.
  Davis, CA 95618
  USA
  
• Kim Russo
  University of California, Davis
  karusso@ucdavis.edu
  Phone: (530) 754-5022
  1544 Newton Ct.
  Davis, CA 95618
  USA
  

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