Trial Outcomes & Findings for Investigating Accelerated Learning in Healthy Subjects: Trigeminal Nerve Stimulation (NCT NCT03138590)
NCT ID: NCT03138590
Last Updated: 2022-02-03
Results Overview
Changes in performance in the Verbal Paired-Associate memory task is compared between the 2 groups (1. Active tDCS 2. Sham tDCS) to investigate the influence of tDCS on Associative Memory.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
1 week after stimualtion
Results posted on
2022-02-03
Participant Flow
Participant milestones
| Measure |
Active tDCS
Active transcranial Direct Current Stimulation targeting the trigeminal nerve
Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve
|
Sham tDCS
Sham transcranial Direct Current Stimulation targeting the trigeminal nerve
Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigating Accelerated Learning in Healthy Subjects: Trigeminal Nerve Stimulation
Baseline characteristics by cohort
| Measure |
Active tDCS
n=10 Participants
Active transcranial Direct Current Stimulation targeting the trigeminal nerve
Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve
|
Sham tDCS
n=10 Participants
Sham transcranial Direct Current Stimulation targeting the trigeminal nerve
Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.5 years
STANDARD_DEVIATION 4.67 • n=5 Participants
|
21.1 years
STANDARD_DEVIATION 2.33 • n=7 Participants
|
21.3 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Beck Depression Inventory Scale
|
5 units on a scale
STANDARD_DEVIATION 5.65 • n=5 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 4.34 • n=7 Participants
|
4.65 units on a scale
STANDARD_DEVIATION 4.92 • n=5 Participants
|
|
Beck Anxiety Inventory Scale
|
2.6 units on a scale
STANDARD_DEVIATION 2.07 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 2.99 • n=7 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Mini Mental State Examination
|
29.3 units on a scale
STANDARD_DEVIATION 1.06 • n=5 Participants
|
29.5 units on a scale
STANDARD_DEVIATION 0.972 • n=7 Participants
|
29.4 units on a scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 week after stimualtionChanges in performance in the Verbal Paired-Associate memory task is compared between the 2 groups (1. Active tDCS 2. Sham tDCS) to investigate the influence of tDCS on Associative Memory.
Outcome measures
| Measure |
Active tDCS
n=10 Participants
Active transcranial Direct Current Stimulation targeting the trigeminal nerve
Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve
|
Sham tDCS
n=10 Participants
Sham transcranial Direct Current Stimulation targeting the trigeminal nerve
Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve
|
|---|---|---|
|
Associative Memory Assessed by a Verbal Paired-Associate Test
|
32.9 percentage of words recalled from V1
Standard Deviation 16.2
|
38.1 percentage of words recalled from V1
Standard Deviation 18.6
|
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
Dr. Sven Vanneste, Principal Investigator
University of Texas at Dallas
Phone: 972-883-7277
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place