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Cognitive Rehabilitation in Parkinson's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085968
First Posted: March 12, 2010
Last Update Posted: October 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Louisiana State University Health Sciences Center Shreveport
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: July 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Parkinson's Disease
Intervention: Behavioral: PC based training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were assigned to group depending on disease status

Reporting Groups
  Description
PD Subjects

PD subjects

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.

Control Subjects

Age matched controls

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.


Participant Flow:   Overall Study
    PD Subjects   Control Subjects
STARTED   29   25 
COMPLETED   19   21 
NOT COMPLETED   10   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Multivariate Analysis of Variance was performed to identify differences across groups in baseline characteristics

Reporting Groups
  Description
PD Subjects

PD subjects

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.

Control Subjects

Age matched controls

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.

Total Total of all reporting groups

Baseline Measures
   PD Subjects   Control Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   25   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.965  (6.450)   65.56  (6.777)   66.852  (6.651) 
Gender 
[Units: Participants]
     
Female   10   10   20 
Male   19   15   34 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   2   3 
Not Hispanic or Latino   28   23   51 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   29   25   54 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reaction Time and Variability for Movement Task   [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ]

2.  Secondary:   Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion   [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ]

3.  Secondary:   Task Errors and Variability   [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ]

4.  Secondary:   Functional Dexterity Test (FDT)   [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ]

5.  Secondary:   Symbol Digit Modality Test (SDMT)   [ Time Frame: time of enrollment and 2 months following enrollment (before and after training) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Elizabeth Disbrow
Organization: VA Overton Brooks
phone: 318-6757184
e-mail: edisbr@lsuhsc.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01085968     History of Changes
Other Study ID Numbers: E7185-R
First Submitted: March 10, 2010
First Posted: March 12, 2010
Results First Submitted: July 5, 2016
Results First Posted: October 11, 2016
Last Update Posted: October 11, 2016