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Cognitive Stimulation Study (CogStim)

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ClinicalTrials.gov Identifier: NCT02067689
Recruitment Status : Recruiting
First Posted : February 20, 2014
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment
Healthy Device: Transcranial Direct Current Stimulation

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Study Design
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Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuromodulation of Cognitive Function Using Transcranial Direct Current Stimulation
Actual Study Start Date : January 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Hemisphere Stimulation
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
Application of a weak electrical current to the scalp
Other Names:
  • Soterix DC Stimulator
  • Neuroconn DC Stimulator MR
Temporal Lobe Stimulation
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
Application of a weak electrical current to the scalp
Other Names:
  • Soterix DC Stimulator
  • Neuroconn DC Stimulator MR
Frontal Lobe Stimulation
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
Application of a weak electrical current to the scalp
Other Names:
  • Soterix DC Stimulator
  • Neuroconn DC Stimulator MR
Parietal Lobe Stimulation
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
Application of a weak electrical current to the scalp
Other Names:
  • Soterix DC Stimulator
  • Neuroconn DC Stimulator MR
Supplementary Motor Stimulation
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
Application of a weak electrical current to the scalp
Other Names:
  • Soterix DC Stimulator
  • Neuroconn DC Stimulator MR
Brain Structure Interactions Group
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
Application of a weak electrical current to the scalp
Other Names:
  • Soterix DC Stimulator
  • Neuroconn DC Stimulator MR


Outcome Measures
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Primary Outcome Measures :
  1. NIH Toolbox Scores [ Time Frame: Baseline ]
  2. NIH Toolbox Scores [ Time Frame: 1 hour after baseline ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults between ages 18-90
Criteria

Inclusion Criteria:

  • Healthy adult
  • Eligible to undergo an MRI

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067689


Contacts
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Contact: Adam J Woods, PhD 352-294-5842 ajwoods@ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Adam J Woods, PhD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Adam J Woods, PhD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02067689     History of Changes
Other Study ID Numbers: IRB201300836
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Normal cognition in healthy adults
Cognitive function
Transcranial direct current stimulation
Structural Magnetic Resonance Imaging
Functional Magnetic Resonance Imaging