NCT03467698

Brief Summary

The overall objective of this study is to explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 9, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

4.6 years

First QC Date

February 28, 2018

Results QC Date

October 3, 2023

Last Update Submit

December 19, 2023

Conditions

Keywords

AgingMemoryAssociative learningtranscranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

  • A Computerized Verbal Paired-associate Memory Task Will be Used to Assess Memory Performance.

    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).

    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)

Study Arms (2)

Active tDCS

EXPERIMENTAL

active HD-tDCS will be administered

Device: Active tDCS

Sham tDCS

SHAM COMPARATOR

sham HD-tDCS will be administered

Device: Sham tDCS

Interventions

Real stimulation

Active tDCS
Sham tDCSDEVICE

Sham stimulation

Sham tDCS

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 55 and 75
  • Currently not using any medication contradicting with tDCS
  • Native English speaker
  • Capable of understanding and signing an informed consent

You may not qualify if:

  • Acquainted with the Swahili language or culture
  • Severe disease
  • Mental illness
  • Cardiac history
  • History of severe head injuries
  • History of epileptic insults
  • Any implanted devices such as pace maker, neurostimulator
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Dallas

Richardson, Texas, 75080, United States

Location

Related Publications (1)

  • Luckey AM, McLeod SL, Robertson IH, To WT, Vanneste S. Greater Occipital Nerve Stimulation Boosts Associative Memory in Older Individuals: A Randomized Trial. Neurorehabil Neural Repair. 2020 Nov;34(11):1020-1029. doi: 10.1177/1545968320943573. Epub 2020 Sep 23.

Results Point of Contact

Title
UT Dallas IRB DIrector
Organization
UT Dallas

Study Officials

  • Sven Vanneste, PhD

    The University of Texas at Dallas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two groups: (1) active tDCS (2) Sham tDCS.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 16, 2018

Study Start

February 21, 2018

Primary Completion

September 17, 2022

Study Completion

October 21, 2022

Last Updated

January 9, 2024

Results First Posted

January 9, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations