Trial Outcomes & Findings for Investigating Accelerated Learning in Healthy Subjects: Trigeminal Nerve Stimulation (NCT 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

Target enrollment

20 participants

Primary outcome timeframe

1 week after stimualtion

Results posted on

2022-02-03

Participant Flow

Participant milestones

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

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
Sex: Female, Male Male	6 Participants n=99 Participants	1 Participants n=107 Participants	7 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Age, Continuous	21.5 years STANDARD_DEVIATION 4.67 • n=99 Participants	21.1 years STANDARD_DEVIATION 2.33 • n=107 Participants	21.3 years STANDARD_DEVIATION 3.6 • n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	9 Participants n=107 Participants	13 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants	8 Participants n=107 Participants	17 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	4 Participants n=107 Participants	7 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	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants
Beck Depression Inventory Scale	5 units on a scale STANDARD_DEVIATION 5.65 • n=99 Participants	4.3 units on a scale STANDARD_DEVIATION 4.34 • n=107 Participants	4.65 units on a scale STANDARD_DEVIATION 4.92 • n=206 Participants
Beck Anxiety Inventory Scale	2.6 units on a scale STANDARD_DEVIATION 2.07 • n=99 Participants	2.6 units on a scale STANDARD_DEVIATION 2.99 • n=107 Participants	2.6 units on a scale STANDARD_DEVIATION 2.5 • n=206 Participants
Mini Mental State Examination	29.3 units on a scale STANDARD_DEVIATION 1.06 • n=99 Participants	29.5 units on a scale STANDARD_DEVIATION 0.972 • n=107 Participants	29.4 units on a scale STANDARD_DEVIATION 0.99 • n=206 Participants

PRIMARY outcome

Timeframe: 1 week after stimualtion

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.

Outcome measures

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