Trial Outcomes & Findings for Investigating Memory in Healthy Subjects Using Transcranial Direct Current Stimulation (NCT NCT03564353)
NCT ID: NCT03564353
Last Updated: 2022-02-03
Results Overview
Participants got the opportunity to learn the list of 75-word pairs across a total of eight alternating study (S) and test (T) periods. Participants came back for a final test session (all 75 words tested) 7 days later and were asked to give the English translations of Swahili words. A score was calaculated based on the percentage of words (English trnaslations) correctly recalled words.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline and 1 week after the tDCS
Results posted on
2022-02-03
Participant Flow
Participant milestones
| Measure |
C2 Right
memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation
tDCS: tDCS
|
C2 Left
memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation
tDCS: tDCS
|
Trigeminal Nerve
memory task paired with tDCS targeting the Trigeminal Nerve
tDCS: tDCS
|
Cranial 5/6 Nerves
memory task paired with tDCS targeting the fifth cranial nerve (C5)
tDCS: tDCS
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
That was not collected
Baseline characteristics by cohort
| Measure |
C2 Right
n=10 Participants
memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation
tDCS: tDCS
|
C2 Left
n=10 Participants
memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation
tDCS: tDCS
|
Trigeminal Nerve
n=10 Participants
memory task paired with tDCS targeting the Trigeminal Nerve
tDCS: tDCS
|
Cranial 5/6 Nerves
n=10 Participants
memory task paired with tDCS targeting the fifth cranial nerve (C5)
tDCS: tDCS
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
20.9 years
STANDARD_DEVIATION 2.64 • n=10 Participants
|
20.6 years
STANDARD_DEVIATION 2.17 • n=10 Participants
|
22.8 years
STANDARD_DEVIATION 4.6 • n=10 Participants
|
22.7 years
STANDARD_DEVIATION 4.54 • n=10 Participants
|
21.75 years
STANDARD_DEVIATION 3.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
21 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
19 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
—
|
—
|
0 Participants
That was not collected
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
0 Participants
That was not collected
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
—
|
0 Participants
That was not collected
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
0 Participants
Data was not collected
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
—
|
—
|
0 Participants
Data was not collected
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
0 Participants
Data was not collected
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
—
|
—
|
0 Participants
Data was not collected
|
|
Race (NIH/OMB)
White
|
—
|
—
|
—
|
—
|
0 Participants
Data was not collected
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
—
|
—
|
0 Participants
Data was not collected
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
—
|
—
|
0 Participants
Data was not collected
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
40 participants
n=40 Participants
|
|
Beck Depression Inventory Scale
|
4.1 units on a scale
STANDARD_DEVIATION 4.3 • n=10 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 4.43 • n=10 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 3.9 • n=10 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 4.33 • n=10 Participants
|
4.05 units on a scale
STANDARD_DEVIATION 4.21 • n=40 Participants
|
|
Beck Anxiety Inventory Scale
|
7 units on a scale
STANDARD_DEVIATION 13.02 • n=10 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 4.5 • n=10 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 1.95 • n=10 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 3.3 • n=10 Participants
|
3.53 units on a scale
STANDARD_DEVIATION 7.18 • n=40 Participants
|
|
Mini Mental State Examination >25
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
40 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 week after the tDCSParticipants got the opportunity to learn the list of 75-word pairs across a total of eight alternating study (S) and test (T) periods. Participants came back for a final test session (all 75 words tested) 7 days later and were asked to give the English translations of Swahili words. A score was calaculated based on the percentage of words (English trnaslations) correctly recalled words.
Outcome measures
| Measure |
C2 Right
n=10 Participants
memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation
tDCS: tDCS
|
C2 Left
n=10 Participants
memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation
tDCS: tDCS
|
Trigeminal Nerve
n=10 Participants
memory task paired with tDCS targeting the Trigeminal Nerve
tDCS: tDCS
|
Cranial 5/6 Nerves
n=10 Participants
memory task paired with tDCS targeting the fifth cranial nerve (C5)
tDCS: tDCS
|
|---|---|---|---|---|
|
Associative Memory Assessed by a Verbal Paired-Associate Test
|
50.6 percentage
Standard Error 6.88
|
50.78 percentage
Standard Error 6.88
|
32.77 percentage
Standard Error 6.88
|
30.25 percentage
Standard Error 6.88
|
Adverse Events
Memory Task With tDCS Location 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Memory Task With tDCS Location 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Memory Task With tDCS Location 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Memory Task With tDCS Location 4
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place