Trial Outcomes & Findings for Cognitive Rehabilitation in Parkinson's Disease (NCT NCT01085968)
NCT ID: NCT01085968
Last Updated: 2016-10-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
54 participants
Primary outcome timeframe
time of enrollment and 2 months following enrollment (before and after training)
Results posted on
2016-10-11
Participant Flow
Participants were assigned to group depending on disease status
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
25
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Rehabilitation in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
PD Subjects
n=29 Participants
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
n=25 Participants
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
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.965 years
STANDARD_DEVIATION 6.450 • n=5 Participants
|
65.56 years
STANDARD_DEVIATION 6.777 • n=7 Participants
|
66.852 years
STANDARD_DEVIATION 6.651 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
25 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: time of enrollment and 2 months following enrollment (before and after training)Population: 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
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.
Outcome measures
| Measure |
PD Subjects
n=19 Participants
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
n=21 Participants
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.
|
|---|---|---|
|
Reaction Time and Variability for Movement Task
After-Left External Cue Reaction Time
|
723.402193 milliseconds
Standard Deviation 197.3197509
|
665.95125 milliseconds
Standard Deviation 93.82810385
|
|
Reaction Time and Variability for Movement Task
After-Right External Cue Reaction Time
|
684.8451754 milliseconds
Standard Deviation 187.8980546
|
609.0429167 milliseconds
Standard Deviation 93.12353905
|
|
Reaction Time and Variability for Movement Task
After-Bimanual External Cue Reaction Time
|
730.595614 milliseconds
Standard Deviation 209.7713843
|
626.12875 milliseconds
Standard Deviation 98.01583054
|
|
Reaction Time and Variability for Movement Task
Before-Left External Cue Reaction Time
|
1013.858333 milliseconds
Standard Deviation 177.4262864
|
994.94875 milliseconds
Standard Deviation 176.9697627
|
|
Reaction Time and Variability for Movement Task
Before-Right External Cue Reaction Time
|
979.2450877 milliseconds
Standard Deviation 199.6872689
|
910.9120833 milliseconds
Standard Deviation 170.180081
|
|
Reaction Time and Variability for Movement Task
Before-Bimanual External Cue Reaction Time
|
1071.54693 milliseconds
Standard Deviation 163.2915835
|
1069.631 milliseconds
Standard Deviation 168.0096474
|
|
Reaction Time and Variability for Movement Task
Before-Left Internally Generated Reaction Time
|
763.6505789 milliseconds
Standard Deviation 302.5488871
|
708.4873763 milliseconds
Standard Deviation 232.2714027
|
|
Reaction Time and Variability for Movement Task
Before-Right Internally Generated Reaction Time
|
777.4738004 milliseconds
Standard Deviation 337.0400281
|
663.6865168 milliseconds
Standard Deviation 204.432536
|
|
Reaction Time and Variability for Movement Task
Before-Bimanual Internally Generated Reaction Time
|
945.8269072 milliseconds
Standard Deviation 403.384961
|
774.904215 milliseconds
Standard Deviation 206.3438777
|
|
Reaction Time and Variability for Movement Task
After-Left Internally Generated Reaction Time
|
531.5406167 milliseconds
Standard Deviation 226.8508076
|
407.7467803 milliseconds
Standard Deviation 78.537003
|
|
Reaction Time and Variability for Movement Task
After-Right Internally Generated Reaction Time
|
532.3444019 milliseconds
Standard Deviation 195.9000996
|
402.6036742 milliseconds
Standard Deviation 83.0771526
|
|
Reaction Time and Variability for Movement Task
After-Bimanual Internally Generated Reaction Time
|
575.3801872 milliseconds
Standard Deviation 247.1520766
|
432.5232121 milliseconds
Standard Deviation 92.77491618
|
SECONDARY outcome
Timeframe: time of enrollment and 2 months following enrollment (before and after training)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.
Outcome measures
| Measure |
PD Subjects
n=19 Participants
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
n=21 Participants
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.
|
|---|---|---|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
Before-mEFAP Task 2
|
6.275 Seconds
Standard Deviation 4.183
|
4.933 Seconds
Standard Deviation 0.792
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
Before-mEFAP Task 3
|
18.853 Seconds
Standard Deviation 15.128
|
14.123 Seconds
Standard Deviation 2.776
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
After-mEFAP Task 4
|
22.426 Seconds
Standard Deviation 18.451
|
19.008 Seconds
Standard Deviation 14.091
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
After-mEFAP Task 5
|
10.399 Seconds
Standard Deviation 6.127
|
11.057 Seconds
Standard Deviation 10.976
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
Before-mEFAP Total
|
65.034 Seconds
Standard Deviation 49.781
|
49.936 Seconds
Standard Deviation 10.858
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
Before-mEFAP Task 1
|
6.251 Seconds
Standard Deviation 5.849
|
4.897 Seconds
Standard Deviation 0.838
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
Before-mEFAP Task 4
|
23.957 Seconds
Standard Deviation 23.470
|
16.320 Seconds
Standard Deviation 3.969
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
Before-mEFAP Task 5
|
9.727 Seconds
Standard Deviation 3.274
|
9.654 Seconds
Standard Deviation 3.974
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
After-mEFAP Task 1
|
6.532 Seconds
Standard Deviation 5.307
|
5.919 Seconds
Standard Deviation 4.015
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
After-mEFAP Task 2
|
6.529 Seconds
Standard Deviation 4.658
|
6.029 Seconds
Standard Deviation 3.927
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
After-mEFAP Task 3
|
20.218 Seconds
Standard Deviation 16.079
|
17.151 Seconds
Standard Deviation 11.656
|
|
Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion
After-mEFAP Total
|
66.105 Seconds
Standard Deviation 49.934
|
59.115 Seconds
Standard Deviation 44.468
|
SECONDARY outcome
Timeframe: time of enrollment and 2 months following enrollment (before and after training)Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials
Outcome measures
| Measure |
PD Subjects
n=19 Participants
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
n=21 Participants
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.
|
|---|---|---|
|
Task Errors and Variability
Before-Left External Cue Errors
|
14.36842105 Number of Errors
Standard Deviation 26.38014937
|
6.9 Number of Errors
Standard Deviation 8.540306909
|
|
Task Errors and Variability
Before-Left Internally Generated Errors
|
3.105263158 Number of Errors
Standard Deviation 3.016523695
|
1.85 Number of Errors
Standard Deviation 1.348488433
|
|
Task Errors and Variability
Before-Right Internally Generated Errors
|
3.052631579 Number of Errors
Standard Deviation 3.099707589
|
1.6 Number of Errors
Standard Deviation 1.602629418
|
|
Task Errors and Variability
Before-Bimanual Internally Generated Errors
|
3.578947368 Number of Errors
Standard Deviation 3.254326854
|
1.65 Number of Errors
Standard Deviation 1.496487115
|
|
Task Errors and Variability
After-Left External Cue Errors
|
4.526315789 Number of Errors
Standard Deviation 9.026925286
|
0.35 Number of Errors
Standard Deviation 0.670820393
|
|
Task Errors and Variability
Before-Right External Cue Errors
|
10 Number of Errors
Standard Deviation 15.89199659
|
3.85 Number of Errors
Standard Deviation 4.771350907
|
|
Task Errors and Variability
Before-Bimanual External Cue Errors
|
27.21052632 Number of Errors
Standard Deviation 48.54159608
|
11.3 Number of Errors
Standard Deviation 12.85997463
|
|
Task Errors and Variability
After-Right External Cue Errors
|
4.526315789 Number of Errors
Standard Deviation 9.697470581
|
0.15 Number of Errors
Standard Deviation 0.670820393
|
|
Task Errors and Variability
After-Bimanual External Cue Errors
|
7.421052632 Number of Errors
Standard Deviation 14.24903813
|
0.6 Number of Errors
Standard Deviation 1.187655807
|
|
Task Errors and Variability
After-Left Internally Generated Errors
|
1.578947368 Number of Errors
Standard Deviation 2.292882453
|
0.25 Number of Errors
Standard Deviation 0.444261658
|
|
Task Errors and Variability
After-Right Internally Generated Errors
|
1.684210526 Number of Errors
Standard Deviation 2.906938664
|
0.1 Number of Errors
Standard Deviation 0.307793506
|
|
Task Errors and Variability
After-Bimanual Internally Generated Errors
|
2 Number of Errors
Standard Deviation 2.666666667
|
0.35 Number of Errors
Standard Deviation 0.74515982
|
SECONDARY outcome
Timeframe: time of enrollment and 2 months following enrollment (before and after training)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.
Outcome measures
| Measure |
PD Subjects
n=19 Participants
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
n=21 Participants
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.
|
|---|---|---|
|
Functional Dexterity Test (FDT)
Before-Non-dominant Hand 1
|
54.234 Seconds
Standard Deviation 24.115
|
40.585 Seconds
Standard Deviation 18.051
|
|
Functional Dexterity Test (FDT)
Before-Non-dominant Hand 2
|
45.738 Seconds
Standard Deviation 22.573
|
32.193 Seconds
Standard Deviation 11.012
|
|
Functional Dexterity Test (FDT)
Before-Modified Task 1
|
10.034 Seconds
Standard Deviation 2.169
|
10.259 Seconds
Standard Deviation 4.984
|
|
Functional Dexterity Test (FDT)
Before-Modified Task 2
|
9.677 Seconds
Standard Deviation 3.091
|
10.005 Seconds
Standard Deviation 6.149
|
|
Functional Dexterity Test (FDT)
Before-Non-dominant Average
|
49.987 Seconds
Standard Deviation 19.890
|
36.389 Seconds
Standard Deviation 13.175
|
|
Functional Dexterity Test (FDT)
After-Dominant Hand 1
|
44.831 Seconds
Standard Deviation 25.128
|
35.219 Seconds
Standard Deviation 11.564
|
|
Functional Dexterity Test (FDT)
After-Dominant Hand 2
|
41.261 Seconds
Standard Deviation 28.016
|
29.515 Seconds
Standard Deviation 9.231
|
|
Functional Dexterity Test (FDT)
After-Non-dominant Hand 1
|
46.676 Seconds
Standard Deviation 26.151
|
35.914 Seconds
Standard Deviation 15.678
|
|
Functional Dexterity Test (FDT)
After-Non-dominant Hand 2
|
38.403 Seconds
Standard Deviation 20.954
|
34.533 Seconds
Standard Deviation 14.462
|
|
Functional Dexterity Test (FDT)
Before-Dominant Hand 1
|
55.048 Seconds
Standard Deviation 37.158
|
41.440 Seconds
Standard Deviation 13.477
|
|
Functional Dexterity Test (FDT)
Before-Dominant Hand 2
|
47.023 Seconds
Standard Deviation 29.848
|
37.627 Seconds
Standard Deviation 18.291
|
|
Functional Dexterity Test (FDT)
Before-Combined Modified Task
|
19.711 Seconds
Standard Deviation 4.324
|
20.263 Seconds
Standard Deviation 8.854
|
|
Functional Dexterity Test (FDT)
Before-Dominant Hand Average
|
51.032 Seconds
Standard Deviation 32.445
|
39.533 Seconds
Standard Deviation 12.963
|
|
Functional Dexterity Test (FDT)
After-Modified Task 1
|
9.827 Seconds
Standard Deviation 2.169
|
9.976 Seconds
Standard Deviation 4.811
|
|
Functional Dexterity Test (FDT)
After-Modified Task 2
|
9.508 Seconds
Standard Deviation 4.302
|
7.515 Seconds
Standard Deviation 1.718
|
|
Functional Dexterity Test (FDT)
After-Combined Modified Task
|
19.335 Seconds
Standard Deviation 5.969
|
17.492 Seconds
Standard Deviation 5.930
|
|
Functional Dexterity Test (FDT)
After-Dominant Average
|
43.046 Seconds
Standard Deviation 25.748
|
32.367 Seconds
Standard Deviation 9.306
|
|
Functional Dexterity Test (FDT)
After-Non-dominant Average
|
42.539 Seconds
Standard Deviation 22.706
|
35.224 Seconds
Standard Deviation 14.562
|
SECONDARY outcome
Timeframe: time of enrollment and 2 months following enrollment (before and after training)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.
Outcome measures
| Measure |
PD Subjects
n=19 Participants
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
n=21 Participants
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.
|
|---|---|---|
|
Symbol Digit Modality Test (SDMT)
After-SDMT Number Correct in 90 Seconds
|
48.211 Number of Correct Matches in 90 seconds
Standard Deviation 11.424
|
51.000 Number of Correct Matches in 90 seconds
Standard Deviation 9.338
|
|
Symbol Digit Modality Test (SDMT)
Before-SDMT Number Correct in 90 Seconds
|
46.842 Number of Correct Matches in 90 seconds
Standard Deviation 11.644
|
49.286 Number of Correct Matches in 90 seconds
Standard Deviation 8.468
|
Adverse Events
PD Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place