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Cognitive Stimulation Study (CogStim)
This study is currently recruiting participants.
Verified February 2017 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02067689
First received: February 7, 2014
Last updated: February 22, 2017
Last verified: February 2017
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Purpose
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 | Intervention |
|---|---|
| Healthy | Device: Transcranial Direct Current Stimulation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Neuromodulation of Cognitive Function Using Transcranial Direct Current Stimulation |
Further study details as provided by University of Florida:
Primary Outcome Measures:
- NIH Toolbox Scores [ Time Frame: Baseline ]
- NIH Toolbox Scores [ Time Frame: 1 hour after baseline ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2016 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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:
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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:
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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:
|
|
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).
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Device: Transcranial Direct Current Stimulation
Application of a weak electrical current to the scalp
Other Names:
|
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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:
|
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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.
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Device: Transcranial Direct Current Stimulation
Application of a weak electrical current to the scalp
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02067689
Please refer to this study by its ClinicalTrials.gov identifier: NCT02067689
Contacts
| Contact: Adam J Woods, PhD | 352-294-5842 | ajwoods@ufl.edu |
Locations
| 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
| Principal Investigator: | Adam J Woods, PhD | University of Florida |
More Information
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT02067689 History of Changes |
| Other Study ID Numbers: |
IRB201300836 |
| Study First Received: | February 7, 2014 |
| Last Updated: | February 22, 2017 |
| 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 |
ClinicalTrials.gov processed this record on June 23, 2017