Trial Outcomes & Findings for Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation (NCT NCT04647032)
NCT ID: NCT04647032
Last Updated: 2023-05-11
Results Overview
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Post-tACS (1-day follow-up), approximately 1 week after baseline
Results posted on
2023-05-11
Participant Flow
Participant milestones
| Measure |
Theta Stimulation Group
This group will receive 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
This group will receive 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Difficulty level is a continuous unitless quantity that relates to the difficulty of the task. Higher is better.
Baseline characteristics by cohort
| Measure |
Theta Stimulation Group
n=15 Participants
This group will receive 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
n=15 Participants
This group will receive 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 6 • n=5 Participants
|
70 years
STANDARD_DEVIATION 4 • n=7 Participants
|
70 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Divided Attention
|
8.01 difficulty level achieved
STANDARD_DEVIATION 1.56 • n=5 Participants • Difficulty level is a continuous unitless quantity that relates to the difficulty of the task. Higher is better.
|
8.51 difficulty level achieved
STANDARD_DEVIATION 1.65 • n=7 Participants • Difficulty level is a continuous unitless quantity that relates to the difficulty of the task. Higher is better.
|
8.27 difficulty level achieved
STANDARD_DEVIATION 1.61 • n=5 Participants • Difficulty level is a continuous unitless quantity that relates to the difficulty of the task. Higher is better.
|
|
Sustained Attention
|
527 milliseconds
STANDARD_DEVIATION 108 • n=5 Participants • Response times to visual targets. Lower is better.
|
432 milliseconds
STANDARD_DEVIATION 56 • n=7 Participants • Response times to visual targets. Lower is better.
|
481 milliseconds
STANDARD_DEVIATION 82 • n=5 Participants • Response times to visual targets. Lower is better.
|
|
Working Memory
|
6.13 number correct
STANDARD_DEVIATION 0.96 • n=5 Participants • Number of items remembered. Higher is better.
|
6.56 number correct
STANDARD_DEVIATION 0.81 • n=7 Participants • Number of items remembered. Higher is better.
|
6.34 number correct
STANDARD_DEVIATION 0.89 • n=5 Participants • Number of items remembered. Higher is better.
|
|
Instrumental Activities of Daily Living
|
3.92 score on a scale
STANDARD_DEVIATION 0.29 • n=5 Participants • Higher is better (max = 4)
|
4 score on a scale
STANDARD_DEVIATION 0 • n=7 Participants • Higher is better (max = 4)
|
3.96 score on a scale
STANDARD_DEVIATION 0.14 • n=5 Participants • Higher is better (max = 4)
|
PRIMARY outcome
Timeframe: Post-tACS (1-day follow-up), approximately 1 week after baselinePopulation: Only data from participants who completed the full protocol were analyzed.
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Outcome measures
| Measure |
Theta Stimulation Group
n=14 Participants
This group received 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
n=13 Participants
This group received 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
|---|---|---|
|
Divided Attention Performance
|
9.29 difficulty level acheived
Standard Deviation 2.83
|
9.31 difficulty level acheived
Standard Deviation 2.40
|
PRIMARY outcome
Timeframe: Post-tACS (1-month follow-up), approximately 1 month after baselinePopulation: Only data from participants who completed the full protocol were analyzed.
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Outcome measures
| Measure |
Theta Stimulation Group
n=14 Participants
This group received 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
n=13 Participants
This group received 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
|---|---|---|
|
Divided Attention Performance
|
10.10 difficulty level acheived
Standard Deviation 1.40
|
10.67 difficulty level acheived
Standard Deviation 1.18
|
PRIMARY outcome
Timeframe: Post-tACS (1-day follow-up), approximately 1 week after baselinePopulation: Only data from participants who completed the full protocol were analyzed.
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Outcome measures
| Measure |
Theta Stimulation Group
n=14 Participants
This group received 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
n=13 Participants
This group received 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
|---|---|---|
|
Sustained Attention Performance
|
436 milliseconds
Standard Deviation 73
|
416 milliseconds
Standard Deviation 60
|
PRIMARY outcome
Timeframe: Post-tACS (1-month follow-up), approximately 1 month after baselinePopulation: Only data from participants who completed the full protocol were analyzed.
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Outcome measures
| Measure |
Theta Stimulation Group
n=14 Participants
This group received 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
n=13 Participants
This group received 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
|---|---|---|
|
Sustained Attention Performance
|
428 milliseconds
Standard Deviation 64
|
395 milliseconds
Standard Deviation 49
|
PRIMARY outcome
Timeframe: Post-tACS (1-day follow-up), approximately 1 week after baselinePopulation: Only data from participants who completed the full protocol were analyzed.
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares.
Outcome measures
| Measure |
Theta Stimulation Group
n=14 Participants
This group received 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
n=13 Participants
This group received 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
|---|---|---|
|
Working Memory Performance
|
6.09 number correct
Standard Deviation 1.29
|
6.89 number correct
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: Post-tACS (1-month follow-up), approximately 1 month after baselinePopulation: Only data from participants who completed the full protocol were analyzed.
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares
Outcome measures
| Measure |
Theta Stimulation Group
n=14 Participants
This group received 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
n=13 Participants
This group received 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
|---|---|---|
|
Working Memory Performance
|
6.13 number correct
Standard Deviation 1.15
|
6.50 number correct
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Post-tACS (1-day follow-up), approximately 1 week after baselinePopulation: Only data from participants who completed the full protocol were analyzed.
Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).
Outcome measures
| Measure |
Theta Stimulation Group
n=14 Participants
This group received 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
n=13 Participants
This group received 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
|---|---|---|
|
Instrumental Activities of Daily Living (IADL)
|
3.92 score on a scale
Standard Deviation 0.29
|
4 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Post-tACS (1-month follow-up), approximately 1 month after baselinePopulation: Only data from participants who completed the full protocol were analyzed.
Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).
Outcome measures
| Measure |
Theta Stimulation Group
n=14 Participants
This group received 6 Hz (theta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
Delta Stimulation Group
n=13 Participants
This group received 1 Hz (delta) stimulation
Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4
|
|---|---|---|
|
Instrumental Activities of Daily Living (IADL)
|
4 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 0
|
Adverse Events
Theta Stimulation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delta Stimulation Group
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. Theodore Zanto
University of California San Francisco
Phone: 415-502-7322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place