Investigating Accelerated Learning in Healthy Subjects: Trigeminal Nerve Stimulation

• Sponsor: The University of Texas at Dallas (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03138590
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 57.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether it is possible to accelerate learning and improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) targeting the trigeminal nerve during a verbal paired-associate learning task

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Device: Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS	N/A

Detailed Description

Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. To investigate whether it is possible to accelerate learning and improve associative memory using tDCS, the performance in a Verbal Paired-Associate memory task of 2 groups will be compared. The first group will get active tDCS during the verbal paired-associate learning task. The second group will get sham tDCS during the verbal paired-associate learning task.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: participants will be randomly assigned to one of 2 groups: (1) active tDCS (2) sham tDCSparticipants will be randomly assigned to one of 2 groups: (1) active tDCS (2) sham tDCS
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Investigating Accelerated Learning in Healthy Subjects
• Actual Study Start Date: Apr 4, 2017
• Actual Primary Completion Date: Jan 25, 2022
• Actual Study Completion Date: Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active tDCS Active transcranial Direct Current Stimulation targeting the trigeminal nerve	Device: Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS; Transcranial Direct Current Stimulation targeting the trigeminal nerve
Sham Comparator: Sham tDCS Sham transcranial Direct Current Stimulation targeting the trigeminal nerve	Device: Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS; Transcranial Direct Current Stimulation targeting the trigeminal nerve

Outcome Measures

Primary Outcome Measures

1. Associative Memory Assessed by a Verbal Paired-Associate Test [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Native English Speaker

Exclusion Criteria:

• History of severe head injuries, epileptic insults, or heart disease.

• Severe psychiatric disorders and severe untreated medical problems

• Acquainted with the foreign language used in the learning task

• Contraindications for tDCS (e.g. pregnant, implanted devices)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas of Dallas	Richardson	Texas	United States	75080

Sponsors and Collaborators

• The University of Texas at Dallas

Investigators

• Principal Investigator: Sven Vanneste, The University of Texas at Dallas

Study Documents (Full-Text)

• Study Protocol: Protocol 17-34 TN - Jan 1, 2016

More Information

Publications

None provided.

• Responsible Party: Sven Vanneste, Associate professor, The University of Texas at Dallas
• ClinicalTrials.gov Identifier: NCT03138590
• Other Study ID Numbers: 17-34 TN
• First Posted: May 3, 2017
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Sven Vanneste, Associate professor, The University of Texas at Dallas: transcranial Direct Current Stimulation (tDCS); accelerate learning; memory

Study Results

Participant Flow

Arm/Group Title	Active tDCS	Sham tDCS
Arm/Group Description	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 transcranial Direct Current Stimulation targeting the trigeminal nerve Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Active tDCS	Sham tDCS	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.5 (4.67)	21.1 (2.33)	21.3 (3.6)
Sex: Female, Male (Count of Participants)
Female	4 40%	9 90%	13 65%
Male	6 60%	1 10%	7 35%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 10%	2 20%	3 15%
Not Hispanic or Latino	9 90%	8 80%	17 85%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 30%	4 40%	7 35%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 40%	2 20%	6 30%
White	3 30%	3 30%	6 30%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 10%	1 5%
Region of Enrollment (Count of Participants)
United States	10 100%	10 100%	20 100%
Beck Depression Inventory Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5 (5.65)	4.3 (4.34)	4.65 (4.92)
Beck Anxiety Inventory Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.6 (2.07)	2.6 (2.99)	2.6 (2.5)
Mini Mental State Examination (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	29.3 (1.06)	29.5 (0.972)	29.4 (0.99)

Outcome Measures

1. Primary Outcome

Title	Associative Memory Assessed by a Verbal Paired-Associate Test
Description	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.
Time Frame	1 week after stimualtion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active tDCS	Sham tDCS
Arm/Group Description	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 transcranial Direct Current Stimulation targeting the trigeminal nerve Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve
Measure Participants	10	10
Mean (Standard Deviation) [percentage of words recalled from V1]	32.9 (16.2)	38.1 (18.6)

Adverse Events

Time Frame	One Week
Adverse Event Reporting Description	Before the end of the experiment, participants were asked to fill out a questionnaire (Brunoni et al., 2011) to assess their experiences of possible side effects (e.g., headache, neck pain, and scalp pain) related to the stimulation on a 4-point scale (1 = absent, 2 = mild, 3 = moderate, and 4 = severe).
Arm/Group Title	Active tDCS		Sham tDCS
Arm/Group Description	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 transcranial Direct Current Stimulation targeting the trigeminal nerve Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve
All Cause Mortality
	Active tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Active tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Active tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.