Trial Outcomes & Findings for Brain and Cognitive Changes After Reasoning Training in Individuals With Mild Cognitive Impairment (NCT NCT02596906)
NCT ID: NCT02596906
Last Updated: 2023-10-30
Results Overview
To examine short-term and long-term effects of treatment on cognition and real-life outcomes. The participant will undergo neuropsychological testing at baseline, post-training (4 weeks), as well as 3-months post-training. Scores on the scale range from 0 to 16 on the California Verbal Learning Task. Higher the values are better their memory.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline to 4 weeks and 3 months post-training
Results posted on
2023-10-30
Participant Flow
22 participants consented for the study of which 15 were included in the final analysis.
331 participants were screened for eligibility criteria, of which 52 participants were eligible for the study. Of the 52, a total of 30 participants dropped out due to time constraints, inability to complete the scans and/or after recommendation by the neurologist who questioned if they truly met eligibility criteria.
Participant milestones
| Measure |
tDCS+Training
This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session.
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Sham tDCS+Training
This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.
Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group.
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|---|---|---|
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Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
Baseline characteristics by cohort
| Measure |
tDCS+Training
n=8 Participants
This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session.
|
Sham tDCS+Training
n=7 Participants
This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.
Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group.
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Total
n=15 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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64.17 years
STANDARD_DEVIATION 6.93 • n=5 Participants • Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
|
63.30 years
STANDARD_DEVIATION 7.38 • n=7 Participants • Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
|
63.91 years
STANDARD_DEVIATION 6.25 • n=5 Participants • Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants • Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
|
6 Participants
n=7 Participants • Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
|
11 Participants
n=5 Participants • Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants • Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
|
1 Participants
n=7 Participants • Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
|
4 Participants
n=5 Participants • Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement.
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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1 Participants
n=7 Participants
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2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
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10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeks and 3 months post-trainingPopulation: 22 participants consented to the study of which 15 participants were in the final analysis
To examine short-term and long-term effects of treatment on cognition and real-life outcomes. The participant will undergo neuropsychological testing at baseline, post-training (4 weeks), as well as 3-months post-training. Scores on the scale range from 0 to 16 on the California Verbal Learning Task. Higher the values are better their memory.
Outcome measures
| Measure |
tDCS+Training
n=8 Participants
This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session.
|
Sham tDCS+Training
n=7 Participants
This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.
Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group.
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|---|---|---|
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Change From Baseline in California Verbal Learning Task Score
Baseline to 4 weeks
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3.04 score on a scale
Standard Deviation 1.22
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5.17 score on a scale
Standard Deviation 2.22
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Change From Baseline in California Verbal Learning Task Score
Baseline to 3-month follow-up
|
4.22 score on a scale
Standard Deviation 1.45
|
7.04 score on a scale
Standard Deviation 1.44
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SECONDARY outcome
Timeframe: Two longitudinal measurements at baseline and 1-monthPopulation: Participants between ages 50-80 years had a diagnosis of mild cognitive impairment (MCI)based on Petersen's or Alzheimer's Disease Neuroimaging Initiative (ADNI) criteria from the Dallas-Fort worth community.
Non-invasive estimation of rCBF by perfusion maps using pseudo-continuous arterial spin labeling (pCASL) MRI. rCBF is quantified as mL/min/100g tissue.
Outcome measures
| Measure |
tDCS+Training
n=8 Participants
This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session.
|
Sham tDCS+Training
n=7 Participants
This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.
Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group.
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|---|---|---|
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Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation
|
0.19 ml/min/100g tissue scaled by whole brain
Interval 0.04 to 0.34
|
-0.12 ml/min/100g tissue scaled by whole brain
Interval -0.27 to 0.03
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Adverse Events
tDCS+Training
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham tDCS+Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
tDCS+Training
n=8 participants at risk
This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session.
|
Sham tDCS+Training
n=7 participants at risk
This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.
Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group.
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|---|---|---|
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Gastrointestinal disorders
Baseline at 1pm on June 26th 2017 for 15 minutes
|
12.5%
1/8 • Number of events 1 • Baseline to 4 months
Two participants had adverse events in the study: 1 participant had a minor burn from the tDCS and a 2nd participant became dizzy and vomited at the scanner.
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0.00%
0/7 • Baseline to 4 months
Two participants had adverse events in the study: 1 participant had a minor burn from the tDCS and a 2nd participant became dizzy and vomited at the scanner.
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Injury, poisoning and procedural complications
Baseline on February 26th 2017 for 1week on March 2nd 2017
|
12.5%
1/8 • Number of events 1 • Baseline to 4 months
Two participants had adverse events in the study: 1 participant had a minor burn from the tDCS and a 2nd participant became dizzy and vomited at the scanner.
|
0.00%
0/7 • Baseline to 4 months
Two participants had adverse events in the study: 1 participant had a minor burn from the tDCS and a 2nd participant became dizzy and vomited at the scanner.
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Additional Information
Dr. Namrata Das
Center for BrainHealth, The university of Texas at Dallas
Phone: 9728833266
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place