Investigating Memory in Healthy Subjects Using Transcranial Direct Current Stimulation

• Sponsor: The University of Texas at Dallas (Other)
• Overall Status: Completed
• CT.gov ID: NCT03564353
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4
• Actual Duration (Months): 43.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether we can improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) during a verbal paired-associate learning task

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Device: tDCS	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 improve associative memory using tDCS, the performance in a Verbal Paired-Associate memory task of 4 groups targeting different areas will be compared.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomly assigned to one of four groups: (1) tDCS targeting location 1 paired with memory task (2) tDCS targeting location 2 with memory task (3) tDCS targeting location 3 paired with memory task (4) tDCS targeting location 4 paired with memory taskParticipants will be randomly assigned to one of four groups: (1) tDCS targeting location 1 paired with memory task (2) tDCS targeting location 2 with memory task (3) tDCS targeting location 3 paired with memory task (4) tDCS targeting location 4 paired with memory task
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Investigating Memory in Healthy Subjects Using Transcranial Direct Current Stimulation
• Actual Study Start Date: Jun 7, 2018
• Actual Primary Completion Date: Jan 25, 2022
• Actual Study Completion Date: Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: memory task with tDCS location 1 memory task paired with tDCS targeting C2 nerve (anode left c2; cathode right C2)	Device: tDCS; tDCS
Experimental: memory task with tDCS location 2 memory task paired with tDCS targeting C2 nerve (anode right c2; cathode left C2)	Device: tDCS; tDCS
Experimental: memory task with tDCS location 3 memory task paired with tDCS targeting C5/6 nerve	Device: tDCS; tDCS
Experimental: memory task with tDCS location 4 memory task paired with tDCS targeting trigeminal nerve dermatomes (left and right temple/jaw)	Device: tDCS; tDCS

Outcome Measures

Primary Outcome Measures

1. Associative Memory Assessed by a Verbal Paired-Associate Test [Baseline and 1 week after the tDCS]

   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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Age: 18-35 years

• 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 (pregnant women, 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

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 1, 2016

More Information

Publications

None provided.

• Responsible Party: Sven Vanneste, Associate Professor, The University of Texas at Dallas
• ClinicalTrials.gov Identifier: NCT03564353
• Other Study ID Numbers: 17-34 CM
• First Posted: Jun 20, 2018
• 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); memory

Study Results

Participant Flow

Arm/Group Title	C2 Right	C2 Left	Trigeminal Nerve	Cranial 5/6 Nerves
Arm/Group Description	memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation tDCS: tDCS	memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation tDCS: tDCS	memory task paired with tDCS targeting the Trigeminal Nerve tDCS: tDCS	memory task paired with tDCS targeting the fifth cranial nerve (C5) tDCS: tDCS
Period Title: Overall Study
STARTED	10	10	10	10
COMPLETED	10	10	10	10
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	C2 Right	C2 Left	Trigeminal Nerve	Cranial 5/6 Nerves	Total
Arm/Group Description	memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation tDCS: tDCS	memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation tDCS: tDCS	memory task paired with tDCS targeting the Trigeminal Nerve tDCS: tDCS	memory task paired with tDCS targeting the fifth cranial nerve (C5) tDCS: tDCS	Total of all reporting groups
Overall Participants	10	10	10	10	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.9 (2.64)	20.6 (2.17)	22.8 (4.6)	22.7 (4.54)	21.75 (3.6)
Sex: Female, Male (Count of Participants)
Female	5 50%	6 60%	5 50%	5 50%	21 52.5%
Male	5 50%	4 40%	5 50%	5 50%	19 47.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	0 0%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	10 100%	10 100%	40 100%
Beck Depression Inventory Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.1 (4.3)	4.6 (4.43)	2.6 (3.9)	4.9 (4.33)	4.05 (4.21)
Beck Anxiety Inventory Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7 (13.02)	2.9 (4.5)	1.6 (1.95)	2.6 (3.3)	3.53 (7.18)
Mini Mental State Examination >25 (Count of Participants)
Count of Participants [Participants]	10 100%	10 100%	10 100%	10 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Associative Memory Assessed by a Verbal Paired-Associate Test
Description	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.
Time Frame	Baseline and 1 week after the tDCS

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	C2 Right	C2 Left	Trigeminal Nerve	Cranial 5/6 Nerves
Arm/Group Description	memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation tDCS: tDCS	memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation tDCS: tDCS	memory task paired with tDCS targeting the Trigeminal Nerve tDCS: tDCS	memory task paired with tDCS targeting the fifth cranial nerve (C5) tDCS: tDCS
Measure Participants	10	10	10	10
Mean (Standard Error) [percentage]	50.6 (6.88)	50.78 (6.88)	32.77 (6.88)	30.25 (6.88)

Adverse Events

Time Frame	two weeks
Adverse Event Reporting Description	TES Adverse events. We use the tDCS Exit questionnaire developed by Brunoni et al. (36) to assess potential side-effect (headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, trouble concentrating, mood changes).
Arm/Group Title	Memory Task With tDCS Location 1		Memory Task With tDCS Location 2		Memory Task With tDCS Location 3		Memory Task With tDCS Location 4
Arm/Group Description	memory task paired with tDCS targeting location 1 tDCS: tDCS		memory task paired with tDCS targeting location 2 tDCS: tDCS		memory task paired with tDCS targeting location 3 tDCS: tDCS		memory task paired with tDCS targeting location 4 tDCS: tDCS
All Cause Mortality
	Memory Task With tDCS Location 1		Memory Task With tDCS Location 2		Memory Task With tDCS Location 3		Memory Task With tDCS Location 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Memory Task With tDCS Location 1		Memory Task With tDCS Location 2		Memory Task With tDCS Location 3		Memory Task With tDCS Location 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Memory Task With tDCS Location 1		Memory Task With tDCS Location 2		Memory Task With tDCS Location 3		Memory Task With tDCS Location 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.