Trial Outcomes & Findings for Cognitive Training in Parkinson Study (NCT NCT02920632)
NCT ID: NCT02920632
Last Updated: 2024-09-19
Results Overview
Change in executive function after eight weeks of cognitive training as measured by percentage correct on the Tower of London task. Accuracy is measured in percentage correct (%, range 0-100, higher is considered better).
COMPLETED
NA
167 participants
Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")
2024-09-19
Participant Flow
Participant milestones
| Measure |
Online Cognitive Training 1 (N=68)
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2 (N=68)
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects (N=31)
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
31
|
|
Overall Study
T1 (After Training)
|
67
|
66
|
0
|
|
Overall Study
T2 (6-mnth FU)
|
64
|
62
|
0
|
|
Overall Study
T3 (1-y FU)
|
56
|
53
|
0
|
|
Overall Study
COMPLETED
|
52
|
51
|
29
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Online Cognitive Training 1 (N=68)
n=68 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2 (N=68)
n=68 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects (N=31)
n=29 Participants
Reference group to compare cognitive training effects to
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 8.1 • n=68 Participants
|
62.9 years
STANDARD_DEVIATION 7.0 • n=68 Participants
|
62.3 years
STANDARD_DEVIATION 9.8 • n=29 Participants
|
62.8 years
STANDARD_DEVIATION 8.0 • n=165 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=68 Participants
|
21 Participants
n=68 Participants
|
12 Participants
n=29 Participants
|
66 Participants
n=165 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=68 Participants
|
47 Participants
n=68 Participants
|
17 Participants
n=29 Participants
|
99 Participants
n=165 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Unified PD Rating Scale-III - motor score (UPDRS-III)
|
20.2 units on the motor score scale
STANDARD_DEVIATION 8.3 • n=68 Participants • UPDRS-III not taken in healthy controls (disease-specific measure)
|
21.0 units on the motor score scale
STANDARD_DEVIATION 9.5 • n=68 Participants • UPDRS-III not taken in healthy controls (disease-specific measure)
|
—
|
20.6 units on the motor score scale
STANDARD_DEVIATION 8.9 • n=136 Participants • UPDRS-III not taken in healthy controls (disease-specific measure)
|
|
Montreal Cognitive Assessment (MoCA)
|
26.3 units on the MoCA scale
STANDARD_DEVIATION 2.0 • n=68 Participants
|
25.9 units on the MoCA scale
STANDARD_DEVIATION 2.3 • n=68 Participants
|
28.2 units on the MoCA scale
STANDARD_DEVIATION 1.5 • n=29 Participants
|
26.5 units on the MoCA scale
STANDARD_DEVIATION 2.2 • n=165 Participants
|
|
Beck Depression Inventory (BDI)
|
8.2 units on the BDI scale
STANDARD_DEVIATION 4.0 • n=68 Participants
|
7.9 units on the BDI scale
STANDARD_DEVIATION 4.1 • n=68 Participants
|
4.3 units on the BDI scale
STANDARD_DEVIATION 4.2 • n=29 Participants
|
7.3 units on the BDI scale
STANDARD_DEVIATION 4.3 • n=165 Participants
|
PRIMARY outcome
Timeframe: Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")Population: Number analyzed lower due to difficulty understanding the task, or no follow-up assessment in PD group and difficulty understanding the task (n=1) in healthy control group. Healthy control subjects did not undergo an intervention and T1 measurement and scores at T1 are therefore not supplied for this subgroup.
Change in executive function after eight weeks of cognitive training as measured by percentage correct on the Tower of London task. Accuracy is measured in percentage correct (%, range 0-100, higher is considered better).
Outcome measures
| Measure |
Online Cognitive Training 1
n=62 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=64 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
n=28 Participants
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Accuracy on the Tower of London Task
Baseline - T0
|
81.2 percentage of correct responses
Standard Deviation 9.1
|
82.3 percentage of correct responses
Standard Deviation 7.9
|
88.1 percentage of correct responses
Standard Deviation 5.8
|
|
Accuracy on the Tower of London Task
eight weeks - T1
|
84.0 percentage of correct responses
Standard Deviation 10.4
|
84.9 percentage of correct responses
Standard Deviation 8.2
|
—
|
SECONDARY outcome
Timeframe: Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")Population: Questionnaire not taken in healthy control group
Score on subjective cognitive complaints after eight weeks of cognitive training, measured with the Parkinson's disease Cognitive Functional Rating Scale (PD-CFRS), with score range \[0-24\], where higher scores indicate more severe subjective cognitive complaints.
Outcome measures
| Measure |
Online Cognitive Training 1
n=68 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=68 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Total Score on Parkinson's Disease Cognitive Functional Rating Scale
Baseline - T0
|
8.0 score on a scale
Standard Deviation 4.0
|
9.7 score on a scale
Standard Deviation 4.7
|
—
|
|
Total Score on Parkinson's Disease Cognitive Functional Rating Scale
Eight week - T1
|
6.9 score on a scale
Standard Deviation 4.3
|
8.0 score on a scale
Standard Deviation 5.1
|
—
|
SECONDARY outcome
Timeframe: Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")Population: One participant in Online cognitive training 1 did not fill out the questionnaires.
Score on subjective cognitive complaints after eight weeks of cognitive training (T0 to T1), measured by the Cognitive failures questionnaire (CFQ), a questionnaire with range \[0-100\] where a higher score indicates more severe subjective cognitive complaints.
Outcome measures
| Measure |
Online Cognitive Training 1
n=67 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=68 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Total Score on Cognitive Failures Questionnaire
Baseline - T0
|
38.2 scores on a scale
Standard Deviation 10.6
|
38.5 scores on a scale
Standard Deviation 11.5
|
—
|
|
Total Score on Cognitive Failures Questionnaire
Eight week - T1
|
36.9 scores on a scale
Standard Deviation 10.5
|
38.0 scores on a scale
Standard Deviation 12.7
|
—
|
SECONDARY outcome
Timeframe: Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")Population: Number analyzed lower due to difficulty understanding the task (n=7), or no follow-up assessment (n=3) in PD group and difficulty understanding the task (n=1) in healthy control group. Healthy control subjects did not undergo an intervention and T1 measurement and scores at post-intervention are therefore not supplied.
Change on Executive function from T0 to T1, measured with the average reaction time on the Tower of London task over all trials. Reaction time is measured in seconds, where higher reaction time is considered worse.
Outcome measures
| Measure |
Online Cognitive Training 1
n=62 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=64 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
n=28 Participants
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Reaction Time on the Tower of London Task
Baseline - T0
|
12.4 seconds
Standard Deviation 3.2
|
12.7 seconds
Standard Deviation 2.7
|
11.2 seconds
Standard Deviation 2.2
|
|
Reaction Time on the Tower of London Task
Eight weeks - T1
|
11.4 seconds
Standard Deviation 2.9
|
12.1 seconds
Standard Deviation 2.9
|
—
|
SECONDARY outcome
Timeframe: Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")Population: Three participants dropped out of the study and did not perform the T1 measurement and were subsequently removed from analyses. Healthy control subjects did not perform the second assessment.
Executive functions CHANGE after eight weeks of cognitive training (T0 to T1), measured with the Controlled Oral Word Association Test (Letter fluency). Minimum score: 0, there is no maximum score. A higher score indicates better performance.
Outcome measures
| Measure |
Online Cognitive Training 1
n=67 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=66 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
n=29 Participants
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Performance on the Controlled Oral Word Association Test
Baseline (T0)
|
38.0 total number of words produced
Standard Deviation 10.6
|
38.8 total number of words produced
Standard Deviation 11.9
|
43.7 total number of words produced
Standard Deviation 9.7
|
|
Performance on the Controlled Oral Word Association Test
Eight weeks (T1)
|
42.5 total number of words produced
Standard Deviation 12.7
|
42.6 total number of words produced
Standard Deviation 12.5
|
—
|
SECONDARY outcome
Timeframe: Six months after training completion (T2)Population: Healthy control subjects did not undergo follow-up assessment. Number of participants analyzed lower than total population due to drop-out at T2 (n=8) and difficulty understanding the task at one of the time-points (n=11)
Persistence of cognitive training effect on executive functions measured with the accuracy on the Tower of London task six-month after completion of the intervention. Accuracy is measured with mean percentage correct over 100 trials, where a higher percentage correct reflects better cognitive function.
Outcome measures
| Measure |
Online Cognitive Training 1
n=57 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=60 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Performance on Tower of London Accuracy at Six-months Follow-up
|
84.3 percentage of correct responses
Standard Deviation 10.4
|
84.5 percentage of correct responses
Standard Deviation 9.1
|
—
|
SECONDARY outcome
Timeframe: One year after completion of intervention (T3, "Follow-up 2")Population: Healthy control subjects did not undergo follow-up assessments. Number of participants analyzed differs from total sample due to drop-out (n=12), missed assessment (n=15) and difficulty understanding the task (n=2).
Persistence of cognitive training effect on executive functions measured with the accuracy on the Tower of London task one year after completion of the intervention. Accuracy is measured with mean percentage correct over 100 trials, where a higher percentage correct reflects better cognitive function.
Outcome measures
| Measure |
Online Cognitive Training 1
n=55 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=52 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Performance on Tower of London Accuracy at One-year Follow-up
|
83.3 percentage of correct responses
Standard Deviation 14.0
|
84.7 percentage of correct responses
Standard Deviation 10.5
|
—
|
SECONDARY outcome
Timeframe: Two years after completion of the intervention (T4)Population: Healthy control subjects did not undergo follow-up assessemnts. Number of participants analyzed differs from total sample due to drop-out (n=12), missed assessment (n=21) and difficulty understanding the task.
Persistence of cognitive training effect on executive functions measured with the accuracy on the Tower of London task two year after completion of the intervention. Accuracy is measured with mean percentage correct over 100 trials, where a higher percentage correct reflects better cognitive function.
Outcome measures
| Measure |
Online Cognitive Training 1
n=50 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=49 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Performance on Tower of London Accuracy at Two-year Follow-up
|
82.7 percentage of correct responses
Standard Deviation 11.7
|
82.1 percentage of correct responses
Standard Deviation 10.6
|
—
|
SECONDARY outcome
Timeframe: One year after completion of the intervention (T3)Population: Healthy control subjects did not undergo follow-up assessments. Number of participants analyzed differs from total population due to drop-out and missed assessment.
Incidence of conversion of cognitive status at one-year follow-up with respect to the cognitive status at baseline (T0). Cognitive status is defined as cognitively normal (NC), mild cognitive impairment (MCI, according to cognitive aspects of level II MDS criteria), or dementia (according to cognitive aspects of MDS criteria for probable PD dementia). Conversion was defined as -1: conversion to a worse classification (ie, NC to MCI, NC to dementia or MCI to dementia), 0: no change, or 1: conversion to a better classification (ie, dementia to NC, MCI to NC, dementia to MCI).
Outcome measures
| Measure |
Online Cognitive Training 1
n=56 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=53 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Conversion to Mild Cognitive Impairment or Dementia at One-year Follow-up
-1: Conversion to worse classification
|
12 participants
|
11 participants
|
—
|
|
Conversion to Mild Cognitive Impairment or Dementia at One-year Follow-up
0: No change
|
28 participants
|
27 participants
|
—
|
|
Conversion to Mild Cognitive Impairment or Dementia at One-year Follow-up
1: Conversion to better classification
|
16 participants
|
15 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")Population: Three participants dropped out of the study and did not perform the T1 measurement and were subsequently removed from analyses. Healthy control subjects did not perform the second assessment.
Processing speed change after eight weeks of cognitive training, measured with the Stroop Color Word Test (word-reading), where a higher time to completion indicates worse cognitive function.
Outcome measures
| Measure |
Online Cognitive Training 1
n=67 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=66 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
n=29 Participants
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Performance on the Stroop Color-Word Test, Card I
Baseline (T0)
|
54.1 time in seconds
Standard Deviation 10.7
|
56.3 time in seconds
Standard Deviation 15.1
|
49.2 time in seconds
Standard Deviation 9.4
|
|
Performance on the Stroop Color-Word Test, Card I
Eight weeks (T1)
|
50.8 time in seconds
Standard Deviation 9.1
|
54.3 time in seconds
Standard Deviation 13.2
|
—
|
SECONDARY outcome
Timeframe: Baseline (T0, "Pre-intervention") to eight weeks (T1, "Post-intervention")Population: Three participants dropped out of the study and did not perform the T1 measurement and one participant did not undergo card III of the Stroop color word test at T1; these participants were subsequently removed from analyses. Healthy control subjects did not perform the second assessment.
Executive function CHANGE after eight weeks of cognitive training, measured with the Stroop Color Word Test (card III, color-word interference), where a higher time to completion indicates worse cognitive function.
Outcome measures
| Measure |
Online Cognitive Training 1
n=67 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=65 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
n=29 Participants
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Performance on the Stroop Color-Word Test, Card III
Baseline (T0)
|
114.9 time in seconds
Standard Deviation 49.3
|
106.9 time in seconds
Standard Deviation 33.9
|
85.9 time in seconds
Standard Deviation 19.0
|
|
Performance on the Stroop Color-Word Test, Card III
Eight weeks (T1)
|
101.7 time in seconds
Standard Deviation 28.6
|
103.4 time in seconds
Standard Deviation 30.7
|
—
|
SECONDARY outcome
Timeframe: Two year after completion of the intervention (T3)Population: Healthy control subjects did not undergo follow-up assessments. Number of participants analyzed differs from total population due to drop-out and missed assessment.
Count of conversion of cognitive status at two-year follow-up with respect to the cognitive status at baseline (T0). Cognitive status is defined as cognitively normal (NC), mild cognitive impairment (MCI, according to cognitive aspects of level II MDS criteria), or dementia (according to cognitive aspects of MDS criteria for probable PD dementia). Conversion was defined as -1: conversion to a worse classification (ie, NC to MCI, NC to dementia or MCI to dementia), 0: no change, or 1: conversion to a better classification (ie, dementia to NC, MCI to NC, dementia to MCI).
Outcome measures
| Measure |
Online Cognitive Training 1
n=53 Participants
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2
n=51 Participants
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Conversion of Cognitive Status at Two-year Follow-up
-1: Conversion to worse classification
|
13 participants
|
14 participants
|
—
|
|
Conversion of Cognitive Status at Two-year Follow-up
0: No change
|
25 participants
|
27 participants
|
—
|
|
Conversion of Cognitive Status at Two-year Follow-up
1: Conversion to better classification
|
15 participants
|
10 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0)Participants will be classified to cognitive impairment or no cognitive impairment, and their brain network topology will be compared with healthy subjects.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eight weeks (T1)The effect of online cognitive training on brain network topology using resting state fMRI compared with brain network topology of healthy subjects. Healthy subjects will undergo (functional) MRI scanning once.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eight weeks (T1)The effect of online cognitive training on brain activity using resting state fMRI. Regional activity and functional connectivity changes will be assessed after eight weeks of training (T1).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eight weeks (T1)The effect of online cognitive training on structural brain connectivity using DTI. Structural changes will be assessed after eight weeks of training (T1).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Eight weeks (T1)The effect of online cognitive training on brain morphology using MRI. Structural changes will be assessed after eight weeks of training (T1).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0)Demographic characteristic: age at baseline.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0)Demographic characteristic: sex.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0)Demographic characteristic: educational level.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0)Disease characteristic: disease duration.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), one year (T3), two years (T4)Disease characteristic: disease stage (Hoehn and Yahr stage).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Disease characteristic: medication use.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), one year (T3), two years (T4)Motor symptoms assessed by the Unified Parkinson's Disease Rating Scale - III
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Psychiatric symptom severity, depression (Beck Depression Inventory).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Psychiatric symptom severity, including anxiety (Parkinson Anxiety Scale).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Psychiatric symptom severity, including impulse control disorders (QUIP-RS).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Psychiatric symptom severity, including psychotic symptoms (Questionnaire for psychotic events).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Psychiatric symptom severity, including apathy (Apathy Scale).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0)Participants' expectation prior the intervention, measured by the credibility/expectancy questionnaire.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Global cognitive functioning assessed by the Montreal Cognitive Assessment (MoCA).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Global cognitive functioning assessed by the Pentagon copy test, which is predictive of cognitive deterioration.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Attention function, measured by the Stroop task part I: word naming.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Working memory function, measured by the backwards digit span test of the Wechsler adult intelligence test (WAIS)-III.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Episodic memory function, measured by the Dutch version of the Auditory verbal learning test (RAVLT).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Episodic memory function, measured by the Location learning task.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Language function, measured by the Boston naming task.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Language function, measured by the category fluency task.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Visuospatial function, measured by the Benton visual form discrimination task.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Visuospatial function, measured by the Rey complex figure task.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-intervention (T0), eight weeks (T1), six months (T2), one year (T3), two years (T4)Amount of estimated physical activity that a person performs, measured by the New Zealand Physical Activity Questionnaire
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Two years (T4)Estimation of cognitive reserve measured with the Cognitive Reserve Index questionnaire
Outcome measures
Outcome data not reported
Adverse Events
Online Cognitive Training 1 (N=68)
Online Cognitive Training 2 (N=68)
Healthy Control Subjects (N=31)
Serious adverse events
| Measure |
Online Cognitive Training 1 (N=68)
n=68 participants at risk
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2 (N=68)
n=68 participants at risk
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects (N=31)
n=31 participants at risk
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Psychiatric disorders
Impulse control disorder
|
0.00%
0/68 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
1.5%
1/68 • Number of events 1 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
Other adverse events
| Measure |
Online Cognitive Training 1 (N=68)
n=68 participants at risk
Eight-week, three times a week during 45 minutes cognitive training
Online cognitive training 1: Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
|
Online Cognitive Training 2 (N=68)
n=68 participants at risk
Eight-week, three times a week during 45 minutes cognitive activities
Online cognitive training 2: Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
|
Healthy Control Subjects (N=31)
n=31 participants at risk
Reference group to compare cognitive training effects to
|
|---|---|---|---|
|
Nervous system disorders
Medical issue related to PD
|
1.5%
1/68 • Number of events 1 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
4.4%
3/68 • Number of events 3 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
|
General disorders
Training-related adverse event
|
4.4%
3/68 • Number of events 3 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/68 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
|
Infections and infestations
Medical issue not PD-related: COVID
|
0.00%
0/68 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
1.5%
1/68 • Number of events 1 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
|
Infections and infestations
Medical issue other than PD: Ear infection
|
0.00%
0/68 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
1.5%
1/68 • Number of events 1 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
|
Injury, poisoning and procedural complications
Medical issue other than PD: injury
|
2.9%
2/68 • Number of events 2 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
4.4%
3/68 • Number of events 3 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
|
Nervous system disorders
Medical issue other than PD: meningioma
|
1.5%
1/68 • Number of events 2 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/68 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
|
Nervous system disorders
Medical issue other than PD: cerebral infarction
|
1.5%
1/68 • Number of events 1 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
1.5%
1/68 • Number of events 1 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
|
General disorders
Medical issue other than PD: Restless legs and hyperventilation
|
1.5%
1/68 • Number of events 1 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/68 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
|
General disorders
Medical issue other than PD: dizziness
|
0.00%
0/68 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
1.5%
1/68 • Number of events 1 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
0.00%
0/31 • 2 years (duration of study)
No serious adverse events related to the intervention were expected due to the non-pharmacological nature of the intervention. We did collect information on the development of impulse control disorders to gain information about the risk of developing internet/gaming addiction as a result of cognitive training. Adverse events were logged.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place