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Cognitive Rehabilitation in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01085968
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Collaborator:
Louisiana State University Health Sciences Center Shreveport
Information provided by (Responsible Party):
VA Office of Research and Development

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
Enrollment 54
Recruitment Details  
Pre-assignment Details Participants were assigned to group depending on disease status
Arm/Group Title PD Subjects Control Subjects
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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.

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.

Period Title: Overall Study
Started 29 25
Completed 19 21
Not Completed 10 4
Arm/Group Title PD Subjects Control Subjects Total
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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.

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 of all reporting groups
Overall Number of Baseline Participants 29 25 54
Hide Baseline Analysis Population Description
Multivariate Analysis of Variance was performed to identify differences across groups in baseline characteristics
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 25 participants 54 participants
67.965  (6.450) 65.56  (6.777) 66.852  (6.651)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 25 participants 54 participants
Female
10
  34.5%
10
  40.0%
20
  37.0%
Male
19
  65.5%
15
  60.0%
34
  63.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 25 participants 54 participants
Hispanic or Latino
1
   3.4%
2
   8.0%
3
   5.6%
Not Hispanic or Latino
28
  96.6%
23
  92.0%
51
  94.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 25 participants 54 participants
29 25 54
1.Primary Outcome
Title Reaction Time and Variability for Movement Task
Hide Description 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 Frame time of enrollment and 2 months following enrollment (before and after training)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PD Subjects: total number of subjects: 29, 8 withdrew from study, 2 had incomplete data. CO Subjects: total number of subjects: 25, 4 withdrew from study
Arm/Group Title PD Subjects Control Subjects
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: milliseconds
Before-Left External Cue Reaction Time 1013.858333  (177.4262864) 994.94875  (176.9697627)
Before-Right External Cue Reaction Time 979.2450877  (199.6872689) 910.9120833  (170.180081)
Before-Bimanual External Cue Reaction Time 1071.54693  (163.2915835) 1069.631  (168.0096474)
Before-Left Internally Generated Reaction Time 763.6505789  (302.5488871) 708.4873763  (232.2714027)
Before-Right Internally Generated Reaction Time 777.4738004  (337.0400281) 663.6865168  (204.432536)
Before-Bimanual Internally Generated Reaction Time 945.8269072  (403.384961) 774.904215  (206.3438777)
After-Left External Cue Reaction Time 723.402193  (197.3197509) 665.95125  (93.82810385)
After-Right External Cue Reaction Time 684.8451754  (187.8980546) 609.0429167  (93.12353905)
After-Bimanual External Cue Reaction Time 730.595614  (209.7713843) 626.12875  (98.01583054)
After-Left Internally Generated Reaction Time 531.5406167  (226.8508076) 407.7467803  (78.537003)
After-Right Internally Generated Reaction Time 532.3444019  (195.9000996) 402.6036742  (83.0771526)
After-Bimanual Internally Generated Reaction Time 575.3801872  (247.1520766) 432.5232121  (92.77491618)
2.Secondary Outcome
Title Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
Hide Description

Modified Emory Functional Ambulatory Profile (mEFAP); mobility test Task 1: 5 meter walk on hard surface; timed. Task 2: 5 meter walk on carpeted surface, timed. Task 3: Timed up and go; rise from chair, walk 3 meters, walk back, sit down in chair, timed.

Task 4: Obstacle course, similar to the Timed up and go, with 2 obstacles to be stepped over while walking forward and coming back; timed.

Task 5: Ascend and descend 5 steps of stairs; timed.

Time Frame time of enrollment and 2 months following enrollment (before and after training)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD Subjects Control Subjects
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: Seconds
Before-mEFAP Task 1 6.251  (5.849) 4.897  (0.838)
Before-mEFAP Task 2 6.275  (4.183) 4.933  (0.792)
Before-mEFAP Task 3 18.853  (15.128) 14.123  (2.776)
Before-mEFAP Task 4 23.957  (23.470) 16.320  (3.969)
Before-mEFAP Task 5 9.727  (3.274) 9.654  (3.974)
After-mEFAP Task 1 6.532  (5.307) 5.919  (4.015)
After-mEFAP Task 2 6.529  (4.658) 6.029  (3.927)
After-mEFAP Task 3 20.218  (16.079) 17.151  (11.656)
After-mEFAP Task 4 22.426  (18.451) 19.008  (14.091)
After-mEFAP Task 5 10.399  (6.127) 11.057  (10.976)
Before-mEFAP Total 65.034  (49.781) 49.936  (10.858)
After-mEFAP Total 66.105  (49.934) 59.115  (44.468)
3.Secondary Outcome
Title Task Errors and Variability
Hide Description Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials
Time Frame time of enrollment and 2 months following enrollment (before and after training)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD Subjects Control Subjects
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: Number of Errors
Before-Left External Cue Errors 14.36842105  (26.38014937) 6.9  (8.540306909)
Before-Right External Cue Errors 10  (15.89199659) 3.85  (4.771350907)
Before-Bimanual External Cue Errors 27.21052632  (48.54159608) 11.3  (12.85997463)
Before-Left Internally Generated Errors 3.105263158  (3.016523695) 1.85  (1.348488433)
Before-Right Internally Generated Errors 3.052631579  (3.099707589) 1.6  (1.602629418)
Before-Bimanual Internally Generated Errors 3.578947368  (3.254326854) 1.65  (1.496487115)
After-Left External Cue Errors 4.526315789  (9.026925286) 0.35  (0.670820393)
After-Right External Cue Errors 4.526315789  (9.697470581) 0.15  (0.670820393)
After-Bimanual External Cue Errors 7.421052632  (14.24903813) 0.6  (1.187655807)
After-Left Internally Generated Errors 1.578947368  (2.292882453) 0.25  (0.444261658)
After-Right Internally Generated Errors 1.684210526  (2.906938664) 0.1  (0.307793506)
After-Bimanual Internally Generated Errors 2  (2.666666667) 0.35  (0.74515982)
4.Secondary Outcome
Title Functional Dexterity Test (FDT)
Hide Description

Functional Dexterity test (FDT): a motor dexterity measurement for hands. Task: Pick up and flip wooden pegs on a 4x4 pegboard in a zig-zag pattern; timed. Task is performed 2 times per hand Modified Task: Interchange 2 columns of of pegs (4 pegs each side) simultaneously. No flipping is required.

5 second penalty to time score for 1.) using the pegboard to help with flipping and 2.) supinating of the hand; per occurrence. 10 second penalty to time score for dropping a peg, per occurrence.

Time Frame time of enrollment and 2 months following enrollment (before and after training)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD Subjects Control Subjects
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: Seconds
Before-Dominant Hand 1 55.048  (37.158) 41.440  (13.477)
Before-Dominant Hand 2 47.023  (29.848) 37.627  (18.291)
Before-Non-dominant Hand 1 54.234  (24.115) 40.585  (18.051)
Before-Non-dominant Hand 2 45.738  (22.573) 32.193  (11.012)
Before-Modified Task 1 10.034  (2.169) 10.259  (4.984)
Before-Modified Task 2 9.677  (3.091) 10.005  (6.149)
Before-Combined Modified Task 19.711  (4.324) 20.263  (8.854)
Before-Dominant Hand Average 51.032  (32.445) 39.533  (12.963)
Before-Non-dominant Average 49.987  (19.890) 36.389  (13.175)
After-Dominant Hand 1 44.831  (25.128) 35.219  (11.564)
After-Dominant Hand 2 41.261  (28.016) 29.515  (9.231)
After-Non-dominant Hand 1 46.676  (26.151) 35.914  (15.678)
After-Non-dominant Hand 2 38.403  (20.954) 34.533  (14.462)
After-Modified Task 1 9.827  (2.169) 9.976  (4.811)
After-Modified Task 2 9.508  (4.302) 7.515  (1.718)
After-Combined Modified Task 19.335  (5.969) 17.492  (5.930)
After-Dominant Average 43.046  (25.748) 32.367  (9.306)
After-Non-dominant Average 42.539  (22.706) 35.224  (14.562)
5.Secondary Outcome
Title Symbol Digit Modality Test (SDMT)
Hide Description

Symbol Digit Modality Test (SDMT): Participants are given a key of numbers (1-9) corresponding to symbols for reference.

Task: Participants are given a page of symbols and are instructed to say aloud the number corresponding to each symbol on the page.

This task is timed for completion and the score is reported as the number of symbol to number matching correct in 90 seconds.

Time Frame time of enrollment and 2 months following enrollment (before and after training)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PD Subjects Control Subjects
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: Number of Correct Matches in 90 seconds
Before-SDMT Number Correct in 90 Seconds 46.842  (11.644) 49.286  (8.468)
After-SDMT Number Correct in 90 Seconds 48.211  (11.424) 51.000  (9.338)
Time Frame Adverse events were monitored for each research participant over the 10-12 week period during which data was collected.
Adverse Event Reporting Description The most likely time that adverse events would be reported was during the 6 weeks of neurorehabilitation training.
 
Arm/Group Title PD Subjects Control Subjects
Hide Arm/Group Description

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.

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.

All-Cause Mortality
PD Subjects Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PD Subjects Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PD Subjects Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/25 (0.00%) 
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
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