Trial Outcomes & Findings for Investigating Transcranial Direct Current Stimulation (tDCS) in Accelerating Learning in a Healthy Older Population (NCT NCT03467698)
NCT ID: NCT03467698
Last Updated: 2024-01-09
Results Overview
Memory performance scores recorded in the computerized verbal paired-associate memory test during each visit will be compared between the two groups (active tDCS and sham tDCS).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Memory performance changes will be assessed in two different visits. First assessment (baseline) on visit 1 (learning), then one-week after during visit 2 (memory)
Results posted on
2024-01-09
Participant Flow
Participant milestones
| Measure |
Active tDCS
active HD-tDCS will be administered
Active tDCS: Real stimulation
|
Sham tDCS
sham HD-tDCS will be administered
Sham tDCS: Sham stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigating Transcranial Direct Current Stimulation (tDCS) in Accelerating Learning in a Healthy Older Population
Baseline characteristics by cohort
| Measure |
Active tDCS
n=15 Participants
active HD-tDCS will be administered
Active tDCS: Real stimulation
|
Sham tDCS
n=15 Participants
sham HD-tDCS will be administered
Sham tDCS: Sham stimulation
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Continuous
|
64.533 years
STANDARD_DEVIATION 5.58 • n=99 Participants
|
64.667 years
STANDARD_DEVIATION 5.78 • n=107 Participants
|
64.60 years
STANDARD_DEVIATION 5.68 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Memory performance changes will be assessed in two different visits. First assessment (baseline) on visit 1 (learning), then one-week after during visit 2 (memory)Memory performance scores recorded in the computerized verbal paired-associate memory test during each visit will be compared between the two groups (active tDCS and sham tDCS).
Outcome measures
| Measure |
Active tDCS
n=15 Participants
active HD-tDCS will be administered
Active tDCS: Real stimulation
|
Sham tDCS
n=15 Participants
sham HD-tDCS will be administered
Sham tDCS: Sham stimulation
|
|---|---|---|
|
A Computerized Verbal Paired-associate Memory Task Will be Used to Assess Memory Performance.
Visit 2 - memory
|
38.036 percentage of words learned/remembered
Standard Error 4.458
|
24.65 percentage of words learned/remembered
Standard Error 3.458
|
|
A Computerized Verbal Paired-associate Memory Task Will be Used to Assess Memory Performance.
Visit 1 - learning
|
52.93 percentage of words learned/remembered
Standard Error 25.87
|
58.93 percentage of words learned/remembered
Standard Error 24.88
|
Adverse Events
Active tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS
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