NCT03319134

Brief Summary

The overall objective of this study is to investigate the neural correlate in retrieval memory task. The aim of the study is to understand the undergoing changes in late positive ERP component during retrieval memory task when stimulating the posterior cingulate cortex (PCC) with High Definition Transcranial Direct Current Stimulation (HD-tDCS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 26, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

2.3 years

First QC Date

October 18, 2017

Results QC Date

April 22, 2020

Last Update Submit

August 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recognition Memory Assessed by a Retrieval Memory Experiment

    Participants had to learn an association between a face and a name. The face-name association memory task was divided into (1) an encoding phase, (2) a consolidation phase, and (3) a retrieval phase. During the encoding phase, participants studied 60 successively presented face-name pairs. Participants were instructed to assess the gender of each face shown to keep participants focused on the task. The encoding phase lasted approximately 5 minutes. This is followed by a consolidation phase where participants were instructed to "sit still, relax, and think about nothing in particular" for 10 minutes. During the retrieval phase, participants were presented with 60 old and 60 new faces and were instructed to assess whether they had seen this face during the encoding phase, or if it was a 'new' face. Participants received active or sham transcranial direct current stimulation targetting the posterior cingulate cortex during retrieval. The outcome is correctly recalled old faces.

    Retrieval Memory is assessed after 90 seconds break following the recognition phase.

Study Arms (3)

active anodal HD-tDCS

EXPERIMENTAL

Active anodal HD-tDCS stimulation applied during memory task

Device: active anodal HD-tDCS

sham HD-tDCS

SHAM COMPARATOR

Sham HD-tDCS stimulation during memory task for comparison

Device: sham HD-tDCS

active cathodal HD-tDCS

EXPERIMENTAL

Active cathodal HD-tDCS stimulation applied during memory task

Device: active cathodal HD-tDCS

Interventions

1\) active anodal HD-tDCS with memory task

active anodal HD-tDCS

2\) sham HD-tDCS with memory task

sham HD-tDCS

3\) active cathodal HD-tDCS with memory task

active cathodal HD-tDCS

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Native English Speaker
  • Currently not using any medication
  • Capable of understanding and signing an informed consent

You may not qualify if:

  • Severe disease
  • Mental illness
  • Cardiac history
  • History of severe head injuries
  • History of epileptic seizures
  • Any implanted devices such as pacemaker, 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

Results Point of Contact

Title
Clinical Trial Manager
Organization
UT Dallas

Study Officials

  • Sven Vanneste

    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 three groups: (1) active HD-tDCS with retrieval memory task, (2) sham HD-tDCS with retrieval memory task, (3) active cathodal HD-tDCS with retrieval memory task
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 24, 2017

Study Start

September 18, 2017

Primary Completion

January 1, 2020

Study Completion

January 30, 2020

Last Updated

August 26, 2020

Results First Posted

August 26, 2020

Record last verified: 2020-08

Locations