Trial Outcomes & Findings for Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI) (NCT NCT00714571)
NCT ID: NCT00714571
Last Updated: 2017-01-04
Results Overview
Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test
COMPLETED
PHASE1
82 participants
Pre-training, post-training, 1 month
2017-01-04
Participant Flow
Participant milestones
| Measure |
MST Healthy Older Adults: Stage 1
Mnemonic strategy training for object location associations for healthy older adults
|
MST MCI: Stage 1
Mnemonic strategy training for object location associations in patients with MCI
|
XP Healthy Older Adults: Stage 1
Repeated exposure for object location associations in healthy older adults
|
XP MCI: Stage 1
Repeated exposure for object location associations in patients with MCI
|
MST Healthy Older Adults: Stage 2
Mnemonic strategy training for face name associations in healthy older adults
|
SCT Healthy Older Adults: Stage 2
Subtracting cues training for face name associations in healthy older adults
|
|---|---|---|---|---|---|---|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
15
|
15
|
|
Stage 1
STARTED
|
12
|
15
|
11
|
14
|
0
|
0
|
|
Stage 1
COMPLETED
|
12
|
15
|
10
|
14
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
15
|
15
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI)
Baseline characteristics by cohort
| Measure |
MST Healthy Older Adults: Stage 1
n=11 Participants
Mnemonic strategy training for object location associations for healthy older adults
|
MST MCI: Stage 1
n=14 Participants
Mnemonic strategy training for object location associations in patients with MCI
|
XP Healthy Older Adults: Stage 1
n=10 Participants
Repeated exposure for object location associations in healthy older adults
|
XP MCI: Stage 1
n=14 Participants
Repeated exposure for object location associations in patients with MCI
|
MST Healthy Older Adults: Stage 2
n=15 Participants
Mnemonic strategy training for face name associations in healthy older adults
|
SCT Healthy Older Adults: Stage 2
n=15 Participants
Subtracting cues training for face name associations in healthy older adults
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
73.5 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
72.5 years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
70.5 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 7.9 • n=31 Participants
|
72.0 years
STANDARD_DEVIATION 7.6 • n=30 Participants
|
71.3 years
STANDARD_DEVIATION 7.9 • n=3 Participants
|
|
Gender
Female
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
51 Participants
n=3 Participants
|
|
Gender
Male
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
28 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
14 participants
n=107 Participants
|
10 participants
n=206 Participants
|
14 participants
n=7 Participants
|
15 participants
n=31 Participants
|
15 participants
n=30 Participants
|
79 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Pre-training, post-training, 1 monthPopulation: MST older adults Stage 1: 1 participant excluded due to undisclosed ongoing chemotherapy treatment XP older adults Stage 1: 1 participant decided not to participate after randomization MST MCI Stage 1: 1 participant diagnosed with Alzheimer's dementia within 1 month of completing study
Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test
Outcome measures
| Measure |
MST Healthy Older Adults: Stage 1
n=11 Participants
Mnemonic strategy training for object location associations for healthy older adults
|
MST MCI: Stage 1
n=14 Participants
Mnemonic strategy training for object location associations in patients with MCI
|
XP Healthy Older Adults: Stage 1
n=10 Participants
Repeated exposure for object location associations in healthy older adults
|
XP MCI: Stage 1
n=14 Participants
Repeated exposure for object location associations in patients with MCI
|
MST Healthy Older Adults: Stage 2
n=15 Participants
Mnemonic strategy training for face name associations in healthy older adults
|
SCT Healthy Older Adults: Stage 2
n=15 Participants
Subtracting cues training for face name associations in healthy older adults
|
|---|---|---|---|---|---|---|
|
Memory Test Accuracy on Trained Stimuli
Pre-training
|
53.9 Percent correct
Standard Deviation 10.2
|
37.6 Percent correct
Standard Deviation 15.0
|
48.9 Percent correct
Standard Deviation 14.5
|
37.3 Percent correct
Standard Deviation 8.7
|
59.8 Percent correct
Standard Deviation 14.0
|
57.6 Percent correct
Standard Deviation 15.3
|
|
Memory Test Accuracy on Trained Stimuli
Post-Training
|
97.0 Percent correct
Standard Deviation 4.0
|
82.5 Percent correct
Standard Deviation 14.7
|
92.0 Percent correct
Standard Deviation 6.9
|
71.4 Percent correct
Standard Deviation 13.2
|
94.9 Percent correct
Standard Deviation 4.8
|
83.7 Percent correct
Standard Deviation 13.7
|
|
Memory Test Accuracy on Trained Stimuli
1-month
|
85.3 Percent correct
Standard Deviation 1.01
|
65.1 Percent correct
Standard Deviation 17.8
|
63.3 Percent correct
Standard Deviation 13.7
|
45.8 Percent correct
Standard Deviation 8.3
|
86.2 Percent correct
Standard Deviation 7.4
|
69.7 Percent correct
Standard Deviation 18.1
|
Adverse Events
MST Healthy Older Adults: Stage 1
MST MCI: Stage 1
XP Healthy Older Adults: Stage 1
XP MCI: Stage 1
MST Healthy Older Adults: Stage 2
SCT Healthy Older Adults: Stage 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Benjamin M. Hampstead
VA Ann Arbor Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place