Trial Outcomes & Findings for Rehabilitation of Attention in Patients With MCI and Brain Subcortical Vascular Changes Using the APT-II (NCT NCT02033850)
NCT ID: NCT02033850
Last Updated: 2019-06-06
Results Overview
Changes in scores (Δ) approach. Delta scores (Δs) were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. All Δs were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. Δs were analyzed using independent sample t tests with treatment as the only independent variable. Scales: * Activities of Daily Living (ADL): preserved items summed into a global score (minimum and maximum values 0-6: higher scores mean a better outcome). * Instrumental Activities of Daily Living (IADL): impaired items summed into a global score (minimum and maximum values 0-8: higher scores mean a worse outcome). * Disability Assessment in Dementia (DAD): 40 dichotomous items summed into a total score and converted into a percentage (minimum and maximum values 0-100: higher scores mean a worse outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Baseline, 6 months and 12 months
Results posted on
2019-06-06
Participant Flow
Participant milestones
| Measure |
APT-II Group
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
APT-II Group
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
unrelated medical reason
|
1
|
1
|
Baseline Characteristics
Rehabilitation of Attention in Patients With MCI and Brain Subcortical Vascular Changes Using the APT-II
Baseline characteristics by cohort
| Measure |
APT-II Group
n=21 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=22 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 6 • n=5 Participants
|
75.9 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
75.1 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Education
|
9 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
7.4 years
STANDARD_DEVIATION 3 • n=7 Participants
|
8.2 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Hypertension
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Hypercholesterolemia
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Diabetes
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Smoking habits
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
History of stroke
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Alcohol consumption
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Mini Mental State Examination
|
27.1 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
25.7 units on a scale
STANDARD_DEVIATION 3.2 • n=7 Participants
|
26.4 units on a scale
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Montreal Cognitive Assessment
|
19.9 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
18.6 units on a scale
STANDARD_DEVIATION 4.4 • n=7 Participants
|
19.2 units on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Activities of Daily Living (preserved items)
|
5.9 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Instrumental Activities of Daily Living (impaired items)
|
1.9 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Disability Assessment in Dementia
|
91.9 units on a scale
STANDARD_DEVIATION 11.9 • n=5 Participants
|
84.2 units on a scale
STANDARD_DEVIATION 17.8 • n=7 Participants
|
88 units on a scale
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Attention Questionnaire
|
15.1 units on a scale
STANDARD_DEVIATION 11.5 • n=5 Participants
|
15.9 units on a scale
STANDARD_DEVIATION 8.5 • n=7 Participants
|
15.5 units on a scale
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
EuroQol (summary index)
|
0.7 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0.7 units on a scale
STANDARD_DEVIATION 0.3 • n=7 Participants
|
0.7 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
EuroQol (visual scale)
|
63.1 units on a scale
STANDARD_DEVIATION 18.3 • n=5 Participants
|
67.3 units on a scale
STANDARD_DEVIATION 17.5 • n=7 Participants
|
65.2 units on a scale
STANDARD_DEVIATION 17.8 • n=5 Participants
|
|
Geriatric Depression Scale
|
4.6 units on a scale
STANDARD_DEVIATION 4 • n=5 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months and 12 monthsChanges in scores (Δ) approach. Delta scores (Δs) were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. All Δs were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. Δs were analyzed using independent sample t tests with treatment as the only independent variable. Scales: * Activities of Daily Living (ADL): preserved items summed into a global score (minimum and maximum values 0-6: higher scores mean a better outcome). * Instrumental Activities of Daily Living (IADL): impaired items summed into a global score (minimum and maximum values 0-8: higher scores mean a worse outcome). * Disability Assessment in Dementia (DAD): 40 dichotomous items summed into a total score and converted into a percentage (minimum and maximum values 0-100: higher scores mean a worse outcome).
Outcome measures
| Measure |
APT-II Group
n=21 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=22 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Functionality in Activities of Daily Living (Changes in Scores Approach)
Δs on DAD (6 vs 12 months)
|
-6.2 units on a scale
Standard Deviation 20.2
|
-3 units on a scale
Standard Deviation 11.1
|
|
Functionality in Activities of Daily Living (Changes in Scores Approach)
Δs on DAD (baseline vs 12 months)
|
-8.4 units on a scale
Standard Deviation 21.1
|
-6.9 units on a scale
Standard Deviation 17.2
|
|
Functionality in Activities of Daily Living (Changes in Scores Approach)
Δs on ADL (baseline vs 6 months)
|
0.1 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0
|
|
Functionality in Activities of Daily Living (Changes in Scores Approach)
Δs on ADL (6 vs 12 months)
|
-0.1 units on a scale
Standard Deviation 0.4
|
-0.2 units on a scale
Standard Deviation 0.7
|
|
Functionality in Activities of Daily Living (Changes in Scores Approach)
Δs on ADL (baseline vs 12 months)
|
0 units on a scale
Standard Deviation 0.9
|
-0.2 units on a scale
Standard Deviation 0.7
|
|
Functionality in Activities of Daily Living (Changes in Scores Approach)
Δs on IADL (baseline vs 6 months)
|
-0.4 units on a scale
Standard Deviation 1.1
|
0 units on a scale
Standard Deviation 0.9
|
|
Functionality in Activities of Daily Living (Changes in Scores Approach)
Δs on IADL (6 vs 12 months)
|
-0.3 units on a scale
Standard Deviation 1.3
|
-1 units on a scale
Standard Deviation 1.7
|
|
Functionality in Activities of Daily Living (Changes in Scores Approach)
Δs on IADL (baseline vs 12 months)
|
-0.7 units on a scale
Standard Deviation 1.1
|
-1 units on a scale
Standard Deviation 1.7
|
|
Functionality in Activities of Daily Living (Changes in Scores Approach)
Δs on DAD (baseline vs 6 months)
|
-2.2 units on a scale
Standard Deviation 10.3
|
-3.9 units on a scale
Standard Deviation 11.3
|
PRIMARY outcome
Timeframe: Baseline, 6 months and 12 monthsChanges in scores (Δ) approach. Delta scores (Δs) were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. All Δs were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. Δs were analyzed using independent sample t tests with treatment as the only independent variable. Scales: * Short Form Health Survey summary scores: Physical and Mental Component Summary (PCS, MCS) (minimum and maximum values 0-100: lower scores mean worse outcome). * EuroQol (EQ): summary index (min-max values 0-1) and visual analogue scale (minimum and maximum values 0-100: higher scores mean better outcome). * Attention Questionnaire (AQ) total score (minimum and maximum values 0-36: higher scores mean worse outcome). * Geriatric Depression Scale (GDS) total score (minimum and maximum values 0-15: higher scores mean worse outcome).
Outcome measures
| Measure |
APT-II Group
n=21 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=22 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Quality of Life (Changes in Scores Approach)
Δs on AQ (baseline vs 6 months)
|
-1.3 units on a scale
Standard Deviation 7.8
|
2.1 units on a scale
Standard Deviation 9.3
|
|
Quality of Life (Changes in Scores Approach)
Δs on AQ (6 vs 12 months)
|
-3.8 units on a scale
Standard Deviation 7.9
|
-3.3 units on a scale
Standard Deviation 5
|
|
Quality of Life (Changes in Scores Approach)
Δs on AQ (baseline vs 12 months)
|
-5.1 units on a scale
Standard Deviation 8.4
|
-1.2 units on a scale
Standard Deviation 10.6
|
|
Quality of Life (Changes in Scores Approach)
Δs on EQ index (baseline vs 6 months)
|
0.1 units on a scale
Standard Deviation 0.2
|
0.1 units on a scale
Standard Deviation 0.2
|
|
Quality of Life (Changes in Scores Approach)
Δs on EQ index (6 vs 12 months)
|
-0.1 units on a scale
Standard Deviation 0.2
|
0 units on a scale
Standard Deviation 0.2
|
|
Quality of Life (Changes in Scores Approach)
Δs on EQ index (baseline vs 12 months)
|
0 units on a scale
Standard Deviation 0.3
|
0.1 units on a scale
Standard Deviation 0.3
|
|
Quality of Life (Changes in Scores Approach)
Δs on EQ visual (baseline vs 6 months)
|
5.2 units on a scale
Standard Deviation 15.3
|
-2.3 units on a scale
Standard Deviation 9.2
|
|
Quality of Life (Changes in Scores Approach)
Δs on EQ visual (6 vs 12 months)
|
-0.2 units on a scale
Standard Deviation 12.9
|
-2 units on a scale
Standard Deviation 15.8
|
|
Quality of Life (Changes in Scores Approach)
Δs on EQ visual (baseline vs 12 months)
|
5 units on a scale
Standard Deviation 14.2
|
-4.3 units on a scale
Standard Deviation 16.6
|
|
Quality of Life (Changes in Scores Approach)
Δs on GDS (baseline vs 6 months)
|
-0.1 units on a scale
Standard Deviation 2.1
|
-0.8 units on a scale
Standard Deviation 2.9
|
|
Quality of Life (Changes in Scores Approach)
Δs on GDS (6 vs 12 months)
|
0 units on a scale
Standard Deviation 2.7
|
0 units on a scale
Standard Deviation 2.9
|
|
Quality of Life (Changes in Scores Approach)
Δs on GDS (baseline vs 12 months)
|
-0.1 units on a scale
Standard Deviation 2.9
|
-0.7 units on a scale
Standard Deviation 2.5
|
|
Quality of Life (Changes in Scores Approach)
Δs on MCS (baseline vs 6 months)
|
1.4 units on a scale
Standard Deviation 5.3
|
3 units on a scale
Standard Deviation 11.4
|
|
Quality of Life (Changes in Scores Approach)
Δs on MCS (6 vs 12 months)
|
-0.1 units on a scale
Standard Deviation 6.2
|
-2.8 units on a scale
Standard Deviation 9.3
|
|
Quality of Life (Changes in Scores Approach)
Δs on MCS (baseline vs 12 months)
|
1.3 units on a scale
Standard Deviation 7
|
0.2 units on a scale
Standard Deviation 9.6
|
|
Quality of Life (Changes in Scores Approach)
Δs on PCS (baseline vs 6 months)
|
-1.1 units on a scale
Standard Deviation 6.5
|
-1.9 units on a scale
Standard Deviation 8.2
|
|
Quality of Life (Changes in Scores Approach)
Δs on PCS (6 vs 12 months)
|
-0.9 units on a scale
Standard Deviation 6.6
|
0.5 units on a scale
Standard Deviation 8.3
|
|
Quality of Life (Changes in Scores Approach)
Δs on PCS (baseline vs 12 months)
|
-2 units on a scale
Standard Deviation 8.1
|
-1.5 units on a scale
Standard Deviation 10.2
|
PRIMARY outcome
Timeframe: Baseline, 6 months and 12 monthsClinically significance approach. The availability of t scores for the Short Form Health Survey (SF-36) Physical and Mental Component Summary scores (MCS, PCS) allowed us to classify each patient evaluation as 'normal well-being' (t score \>40) or 'reduced well-being' (t score ≤40) at each visit (higher scores mean a better outcome). Variations in performance categories over time (baseline vs. 6 month; 6 vs. 12 month; baseline vs. 12 month) were evaluated for each patient and dichotomized as: 'stable or better evaluation' or 'worst evaluation'. Variations in performance categories were analyzed using chi square tests.
Outcome measures
| Measure |
APT-II Group
n=21 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=22 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Quality of Life (Clinically Significance Approach)
MCS outcome (baseline vs 6 months) · Stable/better
|
19 Participants
|
19 Participants
|
|
Quality of Life (Clinically Significance Approach)
MCS outcome (baseline vs 6 months) · Worse
|
2 Participants
|
3 Participants
|
|
Quality of Life (Clinically Significance Approach)
MCS outcome (6 vs 12 months) · Stable/better
|
18 Participants
|
18 Participants
|
|
Quality of Life (Clinically Significance Approach)
MCS outcome (6 vs 12 months) · Worse
|
3 Participants
|
4 Participants
|
|
Quality of Life (Clinically Significance Approach)
MCS outcome (baseline vs 12 months) · Stable/better
|
18 Participants
|
17 Participants
|
|
Quality of Life (Clinically Significance Approach)
MCS outcome (baseline vs 12 months) · Worse
|
3 Participants
|
5 Participants
|
|
Quality of Life (Clinically Significance Approach)
PCS outcome (baseline vs 6 months) · Stable/better
|
16 Participants
|
17 Participants
|
|
Quality of Life (Clinically Significance Approach)
PCS outcome (baseline vs 6 months) · Worse
|
5 Participants
|
5 Participants
|
|
Quality of Life (Clinically Significance Approach)
PCS outcome (6 vs 12 months) · Stable/better
|
16 Participants
|
20 Participants
|
|
Quality of Life (Clinically Significance Approach)
PCS outcome (6 vs 12 months) · Worse
|
5 Participants
|
2 Participants
|
|
Quality of Life (Clinically Significance Approach)
PCS outcome (baseline vs 12 months) · Stable/better
|
14 Participants
|
17 Participants
|
|
Quality of Life (Clinically Significance Approach)
PCS outcome (baseline vs 12 months) · Worse
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end
Delta (Δ) scores were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. A positive Δ score indicates an improvement, while a negative Δ score indicates a worsening. Delta scores were analyzed using independent sample t tests with treatment as the only independent variable. Test battery: Montreal Cognitive Assessment MoCA (minimum and maximum values 0-30); Mini Mental Status Examination MMSE (minimum and maximum values 0-30), Rey Auditory-Verbal Learning RAVL immediate (minimum and maximum values 0-75) and recall (minimum and maximum values 0-15), Short story (minimum and maximum values 0-28), Rey-Osterrieth Complex Figure ROCF copy and recall (minimum and maximum values 0-36), Visual search (minimum and maximum values 0-50), Symbol Digit Modalities Test SDMT (minimum and maximum values 0-110). Higher scores mean better outcome for all tests.
Outcome measures
| Measure |
APT-II Group
n=21 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=22 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Cognitive Performance (Changes in Scores Approach)
Δs on MoCA (baseline vs 6 months)
|
1.1 units on a scale
Standard Deviation 4.1
|
1.1 units on a scale
Standard Deviation 3.4
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on MoCA (6 vs 12 months)
|
0.8 units on a scale
Standard Deviation 3
|
-0.3 units on a scale
Standard Deviation 2.7
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on MoCA (baseline vs 12 months)
|
2 units on a scale
Standard Deviation 3.9
|
0.8 units on a scale
Standard Deviation 4.5
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on MMSE (baseline vs 6 months)
|
-0.3 units on a scale
Standard Deviation 1.9
|
-0.8 units on a scale
Standard Deviation 1.9
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on MMSE (6 vs 12 months)
|
-0.4 units on a scale
Standard Deviation 2.6
|
0.4 units on a scale
Standard Deviation 1.9
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on MMSE (baseline vs 12 months)
|
-0.7 units on a scale
Standard Deviation 2.8
|
-0.3 units on a scale
Standard Deviation 1.8
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on RAVL immediate (baseline vs 6 months)
|
2 units on a scale
Standard Deviation 7.6
|
1.6 units on a scale
Standard Deviation 4.9
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on RAVL immediate (6 vs 12 months)
|
1.8 units on a scale
Standard Deviation 4.9
|
-1.4 units on a scale
Standard Deviation 3.8
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on RAVL immediate (baseline vs 12 months)
|
3.8 units on a scale
Standard Deviation 6.1
|
0.2 units on a scale
Standard Deviation 4.4
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on RAVL recall (baseline vs 6 months)
|
0.3 units on a scale
Standard Deviation 2.2
|
0.4 units on a scale
Standard Deviation 2.5
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on RAVL recall (6 vs 12 months)
|
0.5 units on a scale
Standard Deviation 2.5
|
-0.3 units on a scale
Standard Deviation 2
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on RAVL recall (baseline vs 12 months)
|
0.9 units on a scale
Standard Deviation 2.3
|
0.1 units on a scale
Standard Deviation 2
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on ROCF recall (baseline vs 6 months)
|
-0.4 units on a scale
Standard Deviation 7.4
|
2.3 units on a scale
Standard Deviation 6.7
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on ROCF recall (6 vs 12 months)
|
0.6 units on a scale
Standard Deviation 6.5
|
-1 units on a scale
Standard Deviation 3.7
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on ROCF recall (baseline vs 12 months)
|
0.7 units on a scale
Standard Deviation 9.7
|
1.5 units on a scale
Standard Deviation 5.8
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on short story (baseline vs 6 months)
|
-1.3 units on a scale
Standard Deviation 3.1
|
-0.1 units on a scale
Standard Deviation 2.5
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on short story (6 vs 12 months)
|
0.7 units on a scale
Standard Deviation 2.2
|
0 units on a scale
Standard Deviation 2.9
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on short story (baseline vs 12 months)
|
-0.7 units on a scale
Standard Deviation 2.7
|
-0.1 units on a scale
Standard Deviation 3.2
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on visual search (baseline vs 6 months)
|
-3.4 units on a scale
Standard Deviation 7.1
|
-2.6 units on a scale
Standard Deviation 9.1
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on visual search (6 vs 12 months)
|
0.3 units on a scale
Standard Deviation 6.9
|
-1.5 units on a scale
Standard Deviation 7.3
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on visual search (baseline vs 12 months)
|
-3 units on a scale
Standard Deviation 8.2
|
-4.2 units on a scale
Standard Deviation 9.7
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on SDMT (baseline vs 6 months)
|
1.1 units on a scale
Standard Deviation 5.4
|
-0.3 units on a scale
Standard Deviation 4.1
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on SDMT (6 vs 12 months)
|
-2 units on a scale
Standard Deviation 6.1
|
0.3 units on a scale
Standard Deviation 5.8
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on SDMT (baseline vs 12 months)
|
-0.9 units on a scale
Standard Deviation 4.6
|
-0.1 units on a scale
Standard Deviation 7.8
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on ROCF copy (baseline vs 6 months)
|
-1.5 units on a scale
Standard Deviation 7.9
|
2.3 units on a scale
Standard Deviation 6.7
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on ROCF copy (6 vs 12 months)
|
-0.3 units on a scale
Standard Deviation 6.1
|
-2.8 units on a scale
Standard Deviation 7.3
|
|
Cognitive Performance (Changes in Scores Approach)
Δs on ROCF copy (baseline vs 12 months)
|
-1.6 units on a scale
Standard Deviation 8.8
|
-0.9 units on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end
Delta (Δ) scores were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. A positive Δ score indicates an improvement, while a negative Δ score indicates a worsening. Delta scores were analyzed using independent sample t tests with treatment as the only independent variable. Cognitive tests based on execution time in seconds: Trail Making Test TMT part A (minimum and maximum values 0-300), TMT part B (minimum and maximum values 0-300), and Stroop Test (minimum and maximum values 0-300). Higher scores mean worse outcome.
Outcome measures
| Measure |
APT-II Group
n=21 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=22 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Δs on Stroop test (baseline vs 6 months)
|
0.4 seconds
Standard Deviation 16.4
|
-1.7 seconds
Standard Deviation 25.2
|
|
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Δs on Stroop test (6 vs 12 months)
|
1.7 seconds
Standard Deviation 15.3
|
-3.4 seconds
Standard Deviation 25.6
|
|
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Δs on Stroop test (baseline vs 12 months)
|
2.2 seconds
Standard Deviation 18.4
|
-5.1 seconds
Standard Deviation 26
|
|
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Δs on TMT-A (baseline vs 6 months)
|
-7.7 seconds
Standard Deviation 23.8
|
3.9 seconds
Standard Deviation 28.2
|
|
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Δs on TMT-A (6 vs 12 months)
|
2.9 seconds
Standard Deviation 24.6
|
-11.83 seconds
Standard Deviation 30.7
|
|
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Δs on TMT-A (baseline vs 12 months)
|
-4.8 seconds
Standard Deviation 29.6
|
-13.2 seconds
Standard Deviation 44.9
|
|
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Δs on TMT-B (baseline vs 6 months)
|
24.5 seconds
Standard Deviation 55.9
|
-14.1 seconds
Standard Deviation 48.5
|
|
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Δs on TMT-B (6 vs 12 months)
|
-13.2 seconds
Standard Deviation 51.4
|
-4.2 seconds
Standard Deviation 21
|
|
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Δs on TMT-B (baseline vs 12 months)
|
10.7 seconds
Standard Deviation 45.3
|
-4.6 seconds
Standard Deviation 53.8
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end
Delta (Δ) scores were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. A positive Δ score indicates an improvement, while a negative Δ score indicates a worsening. Delta scores were analyzed using independent sample t tests with treatment as the only independent variable. Cognitive tests based on the total number of words produced: phonemic (minimum and maximum values not applicable) and semantic verbal fluency (minimum and maximum values not applicable). Higher scores mean better outcome for both tests.
Outcome measures
| Measure |
APT-II Group
n=21 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=22 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Cognitive Performance Verbal Fluency (Changes in Scores Approach)
Δs on phonemic fluency (baseline vs 6 months)
|
0 words
Standard Deviation 6.7
|
0.3 words
Standard Deviation 5.4
|
|
Cognitive Performance Verbal Fluency (Changes in Scores Approach)
Δs on phonemic fluency (6 vs 12 months)
|
0.1 words
Standard Deviation 6.4
|
-0.3 words
Standard Deviation 6.5
|
|
Cognitive Performance Verbal Fluency (Changes in Scores Approach)
Δs on phonemic fluency (baseline vs 12 months)
|
0.1 words
Standard Deviation 7.7
|
0 words
Standard Deviation 6.7
|
|
Cognitive Performance Verbal Fluency (Changes in Scores Approach)
Δs on semantic fluency (baseline vs 6 months)
|
-0.5 words
Standard Deviation 5.3
|
0.8 words
Standard Deviation 5
|
|
Cognitive Performance Verbal Fluency (Changes in Scores Approach)
Δs on semantic fluency (6 vs 12 months)
|
-0.1 words
Standard Deviation 5.9
|
0 words
Standard Deviation 5.6
|
|
Cognitive Performance Verbal Fluency (Changes in Scores Approach)
Δs on semantic fluency (baseline vs 12 months)
|
-0.6 words
Standard Deviation 7.2
|
0.8 words
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end
Clinically significance approach. The availability of national norms for the cognitive variables allowed us to classify each patient's performance as 'normal', 'borderline' or 'abnormal' at each visit. Variations in performance categories over time (baseline vs. 6 month; 6 vs. 12 month; baseline vs. 12 month) were evaluated for each patient and dichotomized as: 'stable or better evaluation' or 'worst evaluation'. Variations in performance categories were analyzed using chi square tests. Test battery: * global cognitive functioning: Montreal Cognitive Assessment, MoCA; Mini Mental Status Examination, MMSE * memory: Rey Auditory-Verbal Learning (RAVL) immediate and recall, Short story, Rey-Osterrieth Complex Figure (ROCF) recall * attention/executive function: Trail Making Test part A and B (TMT-A and B), Visual search, Symbol Digit Modalities Test (SDMT), Stroop Test * language: phonemic and semantic verbal fluency * constructional praxis: ROCF copy
Outcome measures
| Measure |
APT-II Group
n=21 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=22 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Cognitive Performance (Clinically Significance Approach)
ROCF copy variations (baseline vs 6 months) · Stable/better
|
20 Participants
|
22 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF copy variations (baseline vs 6 months) · Worst
|
0 Participants
|
0 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF copy variations (6 vs 12 months) · Stable/better
|
18 Participants
|
14 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF copy variations (6 vs 12 months) · Worst
|
1 Participants
|
7 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF copy variations (baseline vs 12 months) · Stable/better
|
19 Participants
|
17 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF copy variations (baseline vs 12 months) · Worst
|
1 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MoCA variations (baseline vs 6 months) · Stable/better
|
18 Participants
|
20 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MoCA variations (baseline vs 6 months) · Worst
|
2 Participants
|
2 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MoCA variations (6 vs 12 months) · Stable/better
|
20 Participants
|
18 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MoCA variations (6 vs 12 months) · Worst
|
1 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MoCA variations (baseline vs 12 months) · Stable/better
|
18 Participants
|
19 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MoCA variations (baseline vs 12 months) · Worst
|
2 Participants
|
3 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MMSE variations (baseline vs 6 months) · Stable/better
|
20 Participants
|
21 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MMSE variations (baseline vs 6 months) · Worst
|
1 Participants
|
1 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MMSE variations (6 vs 12 months) · Stable/better
|
20 Participants
|
21 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MMSE variations (6 vs 12 months) · Worst
|
1 Participants
|
1 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MMSE variations (baseline vs 12 months) · Stable/better
|
20 Participants
|
22 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
MMSE variations (baseline vs 12 months) · Worst
|
1 Participants
|
0 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL immed. variations (baseline vs 6 months) · Stable/better
|
16 Participants
|
21 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL immed. variations (baseline vs 6 months) · Worst
|
5 Participants
|
1 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL immed. variations (6 vs 12 months) · Stable/better
|
20 Participants
|
17 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL immed. variations (6 vs 12 months) · Worst
|
1 Participants
|
5 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL immed. variations (baseline vs 12 months) · Stable/better
|
19 Participants
|
17 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL immed. variations (baseline vs 12 months) · Worst
|
2 Participants
|
5 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL recall variations (baseline vs 6 months) · Stable/better
|
20 Participants
|
17 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL recall variations (baseline vs 6 months) · Worst
|
1 Participants
|
5 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL recall variations (6 vs 12 months) · Stable/better
|
20 Participants
|
18 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL recall variations (6 vs 12 months) · Worst
|
1 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL recall variations (baseline vs 12 months) · Stable/better
|
19 Participants
|
18 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
RAVL recall variations (baseline vs 12 months) · Worst
|
2 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF recall variations (baseline vs 6 months) · Stable/better
|
13 Participants
|
16 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF recall variations (baseline vs 6 months) · Worst
|
5 Participants
|
5 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF recall variations (6 vs 12 months) · Stable/better
|
15 Participants
|
15 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF recall variations (6 vs 12 months) · Worst
|
1 Participants
|
5 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF recall variations (baseline vs 12 months) · Stable/better
|
15 Participants
|
16 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
ROCF recall variations (baseline vs 12 months) · Worst
|
2 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Short story variations (baseline vs 6 months) · Stable/better
|
17 Participants
|
18 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Short story variations (baseline vs 6 months) · Worst
|
4 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Short story variations (6 vs 12 months) · Stable/better
|
20 Participants
|
20 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Short story variations (6 vs 12 months) · Worst
|
1 Participants
|
2 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Short story variations (baseline vs 12 months) · Stable/better
|
19 Participants
|
18 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Short story variations (baseline vs 12 months) · Worst
|
2 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Visual search variations (baseline vs 6 months) · Stable/better
|
15 Participants
|
15 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Visual search variations (baseline vs 6 months) · Worst
|
6 Participants
|
6 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Visual search variations (6 vs 12 months) · Stable/better
|
20 Participants
|
15 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Visual search variations (6 vs 12 months) · Worst
|
1 Participants
|
6 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Visual search variations (baseline vs 12 months) · Stable/better
|
15 Participants
|
13 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Visual search variations (baseline vs 12 months) · Worst
|
6 Participants
|
7 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
SDMT variations (baseline vs 6 months) · Stable/better
|
19 Participants
|
21 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
SDMT variations (baseline vs 6 months) · Worst
|
2 Participants
|
1 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
SDMT variations (6 vs 12 months) · Stable/better
|
19 Participants
|
19 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
SDMT variations (6 vs 12 months) · Worst
|
2 Participants
|
3 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
SDMT variations (baseline vs 12 months) · Stable/better
|
20 Participants
|
18 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
SDMT variations (baseline vs 12 months) · Worst
|
1 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Stroop test variations (baseline vs 6 months) · Stable/better
|
19 Participants
|
20 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Stroop test variations (baseline vs 6 months) · Worst
|
2 Participants
|
2 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Stroop test variations (6 vs 12 months) · Stable/better
|
19 Participants
|
18 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Stroop test variations (6 vs 12 months) · Worst
|
2 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Stroop test variations (baseline vs 12 months) · Stable/better
|
18 Participants
|
17 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Stroop test variations (baseline vs 12 months) · Worst
|
3 Participants
|
5 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-A variations (baseline vs 6 months) · Stable/better
|
15 Participants
|
18 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-A variations (baseline vs 6 months) · Worst
|
6 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-A variations (6 vs 12 months) · Stable/better
|
19 Participants
|
17 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-A variations (6 vs 12 months) · Worst
|
2 Participants
|
5 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-A variations (baseline vs 12 months) · Stable/better
|
18 Participants
|
16 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-A variations (baseline vs 12 months) · Worst
|
3 Participants
|
6 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-B variations (baseline vs 6 months) · Stable/better
|
16 Participants
|
16 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-B variations (baseline vs 6 months) · Worst
|
2 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-B variations (6 vs 12 months) · Stable/better
|
16 Participants
|
15 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-B variations (6 vs 12 months) · Worst
|
2 Participants
|
2 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-B variations (baseline vs 12 months) · Stable/better
|
16 Participants
|
14 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
TMT-B variations (baseline vs 12 months) · Worst
|
3 Participants
|
3 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Phonemic fluency variations (baseline vs 6 months) · Stable/better
|
19 Participants
|
18 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Phonemic fluency variations (baseline vs 6 months) · Worst
|
2 Participants
|
4 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Phonemic fluency variations (6 vs 12 months) · Stable/better
|
19 Participants
|
20 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Phonemic fluency variations (6 vs 12 months) · Worst
|
2 Participants
|
2 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Phonemic fluency variation (baseline vs 12 months) · Stable/better
|
18 Participants
|
19 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Phonemic fluency variation (baseline vs 12 months) · Worst
|
3 Participants
|
3 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Semantic fluency variations (baseline vs 6 months) · Stable/better
|
18 Participants
|
19 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Semantic fluency variations (baseline vs 6 months) · Worst
|
3 Participants
|
3 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Semantic fluency variations (6 vs 12 months) · Stable/better
|
19 Participants
|
19 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Semantic fluency variations (6 vs 12 months) · Worst
|
2 Participants
|
3 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Semantic fluency variation (baseline vs 12 months) · Stable/better
|
18 Participants
|
19 Participants
|
|
Cognitive Performance (Clinically Significance Approach)
Semantic fluency variation (baseline vs 12 months) · Worst
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsData collected during the 1-year follow-up visit were used to evaluate the occurrence of a transition from MCI to dementia according to DSM-V criteria. Chi square test for a 2x2 contingency table was used to compare patients who became demented at 1-year follow-up visit with those who did not, in the two treatment groups.
Outcome measures
| Measure |
APT-II Group
n=21 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=22 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Transition to Dementia
demented at 1-year follow-up
|
3 Participants
|
5 Participants
|
|
Transition to Dementia
stable MCI
|
17 Participants
|
17 Participants
|
|
Transition to Dementia
reverted to normal cognitive function
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: RsfMRI data were available in in 22 patients (12 treated and 10 non-treated) after the exclusion of patients for technical reasons or head movement greater than 2 mm, and patients with incidental non-lacunar infarcts in the cerebral cortex, cerebellum, or brainstem to avoid a possible confounding effect on rsfMRI analysis.
Improvement in long-term brain activity was measured by means of regional homogeneity (ReHo) of resting state functional MRI (rsfMRI) data. Statistical analysis of rsfMRI data was carried out by feeding Z-transformed ReHo data into voxel-wise inter-subject statistics using permutation-based nonparametric inference within the general linear model framework. P-values were calculated employing permutation-based statistics and corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement, and a p-value \<0.05 was considered statistically significant. Z-transformed ReHo differences (12 months-baseline) were computed separately for treated and non-treated patients, and a voxel-wise between-group comparison was used to evaluate the treatment effect . A positive mean of the Z-transformed ReHo differences represents an increase in activation over time (better outcome), and a negative mean represents a decrease in activation over time (worse outcome).
Outcome measures
| Measure |
APT-II Group
n=12 Participants
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group received overall up to 40 hours of individual training administered in one 2-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=10 Participants
Participants in the standard care group did not received cognitive training or rehabilitation interventions, were instructed to have an usual lifestyle, and conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Cognitive Plasticity
Z-transformed ReHo difference in vermis VIIIb
|
0.78 standard Z-values
Interval 0.36 to 1.15
|
-0.66 standard Z-values
Interval -0.97 to -0.34
|
|
Cognitive Plasticity
Z-transformed ReHo difference in right VIIb lobule
|
1.02 standard Z-values
Interval 0.003 to 1.68
|
-0.86 standard Z-values
Interval -1.99 to -0.33
|
|
Cognitive Plasticity
Z-transformed ReHo difference in left VIIb lobule
|
1.31 standard Z-values
Interval 0.22 to 1.66
|
-1.27 standard Z-values
Interval -1.92 to -0.48
|
Adverse Events
APT-II Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard Care Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
APT-II Group
n=23 participants at risk
Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group will receive overall up to 40 hours of individual attention process training. Therapy will be administered in one two-hour session each week over a total of 20 weeks.
|
Standard Care Group
n=23 participants at risk
Participants in the standard care group will not receive cognitive training or rehabilitation interventions, will be instructed to have an usual lifestyle, and will be conventionally provided of medication and clinic consultations
|
|---|---|---|
|
Vascular disorders
Cerebral haemorrhage
|
0.00%
0/23 • 12 months
|
4.3%
1/23 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
4.3%
1/23 • Number of events 1 • 12 months
|
0.00%
0/23 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Prof. Leonardo Pantoni, Principal Investigator
'L. Sacco' Department of Biomedical and Clinical Sciences University of Milan
Phone: 0039-02-50319865
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place