NCT02067689

Brief Summary

This study will evaluate the influence of non-invasive brain stimulation on different elements of cognitive function in healthy persons between the ages of 18-90 years. It will specifically use transcranial direct current stimulation (tDCS) to evaluate the relationship between certain brain structures and cognitive abilities, like attention, working memory, visual search, etc.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable healthy

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

First Submitted

Initial submission to the registry

February 7, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
Last Updated

January 28, 2020

Status Verified

May 1, 2019

Enrollment Period

3.4 years

First QC Date

February 7, 2014

Last Update Submit

January 25, 2020

Conditions

Keywords

Normal cognition in healthy adultsCognitive functionTranscranial direct current stimulationStructural Magnetic Resonance ImagingFunctional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

  • NIH Toolbox Scores

    Baseline

  • NIH Toolbox Scores

    1 hour after baseline

Study Arms (6)

Hemisphere Stimulation

EXPERIMENTAL

Participants will receive 1mA vs. 2mA transcranial direct current stimulation of a) right and b) left brain structures (1x1 stimulation), and sham/placebo stimulation. A subset of participants will undergo right and left brain stimulation, but all will undergo sham stimulation.

Device: Transcranial Direct Current Stimulation

Temporal Lobe Stimulation

EXPERIMENTAL

A group of participants will undergo 1x1 transcranial direct current stimulation of the temporal lobes at 1 mA vs. 2 mA vs. sham stimulation. A second group of participants will undergo 1mA or 2mA stimulation, and sham, in right vs. left structures using 4x1 stimulation (e.g., 1mA left temporal, 1mA right temporal, sham; 2mA left temporal, 2mA right temporal, sham).

Device: Transcranial Direct Current Stimulation

Frontal Lobe Stimulation

EXPERIMENTAL

A group of participants will undergo 1x1 transcranial direct current stimulation of the frontal lobes at 1 mA vs. 2 mA vs. sham stimulation. A second group of participants will undergo 1mA or 2mA stimulation, and sham, in right vs. left frontal structures using 4x1 stimulation (e.g., 1mA left frontal, 1mA right frontal, sham; 2mA left frontal, 2mA right frontal, sham).

Device: Transcranial Direct Current Stimulation

Parietal Lobe Stimulation

EXPERIMENTAL

A group of participants will undergo 1x1 transcranial direct current stimulation of the parietal lobes at 1 mA vs. 2 mA vs. sham stimulation. A second group of participants will undergo 1mA or 2mA stimulation, and sham, in right vs. left parietal lobes using 4x1 stimulation (e.g., 1mA left parietal lobes, 1mA right parietal lobes, sham; 2mA parietal lobes, 2mA right parietal lobes, sham).

Device: Transcranial Direct Current Stimulation

Supplementary Motor Stimulation

EXPERIMENTAL

A group of participants will undergo 1x1 transcranial direct current stimulation of the Supplementary Motor Area at 1mA vs. 2mA vs. sham stimulation. A second group of participants will undergo 1mA or 2mA stimulation, and sham, in right vs. left Supplementary Motor Area using 4x1 stimulation (e.g., 1mA left Supplementary Motor Area, 1mA right Supplementary Motor Area, sham; 2mA left Supplementary Motor Area, 2mA right Supplementary Motor Area, sham).

Device: Transcranial Direct Current Stimulation

Brain Structure Interactions Group

EXPERIMENTAL

This cohort will evaluate the interaction between frontal, parietal, temporal, and SMA regions in cognitive function. To accomplish this goal will require evaluation of change in cognitive and neurocognitive performance following transcranial direct current stimulation of different brain regions within the same subjects. For example, we will evaluate the contribution of frontal, SMA, and parietal regions by asking participants to undergo stimulation sessions at each of these sites, in addition to a sham session.

Device: Transcranial Direct Current Stimulation

Interventions

Application of a weak electrical current to the scalp

Also known as: Soterix DC Stimulator, Neuroconn DC Stimulator MR
Brain Structure Interactions GroupFrontal Lobe StimulationHemisphere StimulationParietal Lobe StimulationSupplementary Motor StimulationTemporal Lobe Stimulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult
  • Eligible to undergo an MRI

You may not qualify if:

  • History of neurologic disease or dementia
  • History of psychiatric disease which required hospitalization, or
  • Current depression
  • History of head trauma with unconsciousness
  • Developmental learning disability (e.g., dyslexia, dyscalculia)
  • History of vital organ failure (e.g., heart, lungs, kidneys, liver)
  • Currently taking any psycho-active medications
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Adam J Woods, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 20, 2014

Study Start

January 1, 2016

Primary Completion

May 10, 2019

Study Completion

May 10, 2019

Last Updated

January 28, 2020

Record last verified: 2019-05

Locations