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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

82 participants

Primary outcome timeframe

Pre-training, post-training, 1 month

Results posted on

2017-01-04

Participant Flow

Participant milestones

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

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 month

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MST MCI: Stage 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

XP Healthy Older Adults: Stage 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

XP MCI: Stage 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MST Healthy Older Adults: Stage 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

SCT Healthy Older Adults: Stage 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Benjamin M. Hampstead

VA Ann Arbor Healthcare System

Phone: 734-763-9259

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place