Cognitive Rehabilitation in Parkinson's Disease

NCT01085968 | Completed Early Phase 1 Results

• 1 other identifier: E7185-R
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Cognitive deficits; fMRI; neuro rehabilitation; Age Matched Controls

Outcome Measures

Primary Outcomes (1)

• Reaction Time and Variability for Movement Task

  Before and after computer training outcome measures: left, right, bimanual external cue reaction time; left, right, bimanual external cue error; left, right, bimanual internally generated reaction time; left, right, bimanual internally generated error for four-digit trials.

  time of enrollment and 2 months following enrollment (before and after training)

Secondary Outcomes (4)

• Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion

  time of enrollment and 2 months following enrollment (before and after training)

• Task Errors and Variability

  time of enrollment and 2 months following enrollment (before and after training)

• Functional Dexterity Test (FDT)

  time of enrollment and 2 months following enrollment (before and after training)

• Symbol Digit Modality Test (SDMT)

  time of enrollment and 2 months following enrollment (before and after training)

Study Arms (2)

PD Subjects

EXPERIMENTAL

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

Behavioral: PC based training

Control Subjects

ACTIVE COMPARATOR

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.

Behavioral: PC based training

Interventions

PC based training BEHAVIORAL

Subjects sit at a computer and type a string of numbers that appears on the screen. As performance improves (# correct), the strings of numbers get longer. They are then instructed to repeat the string from memory. Performing these key entries from memory is a test of internally generated movement initiation.

Also known as: training

Control Subjects; PD Subjects

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of PD dominant on the right side with a Hx of response to dopamine replacement.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Louisiana State University Health Sciences Center Shreveport: collaborator

Related 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;1452:151-64. doi: 10.1016/j.brainres.2012.02.073. Epub 2012 Mar 9.

  PMID: 22459048 RESULT

MeSH Terms

Conditions

Parkinson Disease; Cognition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Elizabeth Disbrow
• Organization: VA Overton Brooks

edisbr@lsuhsc.edu

318-6757184

Study Officials

• Elizabeth A Disbrow, PhD

  Overton Brooks VA Medical Center, Shreveport, LA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 11, 2016
• Results First Posted: October 11, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share