Cerebral Excitability and Cognitive Performance
1 other identifier
interventional
1,500
1 country
1
Brief Summary
This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
1 active site
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
April 15, 2013
CompletedFirst Submitted
Initial submission to the registry
January 11, 2019
CompletedFirst Posted
Study publicly available on registry
January 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2023
CompletedApril 5, 2021
April 1, 2021
10 years
January 11, 2019
April 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Visual perceptual performance
Ability to accurately and efficiently perceive perceptual information, including threat detection, local contrast gradient detection, face memory, and intent appraisal. All are computerized tasks.
36 weeks
Verbal cognitive performance
Ability to accurately and efficiently process verbal information, including verbal cued free association tasks, verbal long-term memory, and language comprehension. All are computerized tasks.
36 weeks
Spatial cognitive performance
Ability to accurately and efficiently process spatial information, including map learning, virtual urban navigation, and mental rotation. All are computerized tasks.
72 weeks
Study Arms (2)
Active High-Definition Stimulation
EXPERIMENTALActive high-definition stimulation of targeted brain regions involved in perception and cognition.
Sham High-Definition Stimulation
SHAM COMPARATORSham high-definition stimulation of targeted brain regions involved in perception and cognition.
Interventions
Active (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.
Eligibility Criteria
You may qualify if:
- \- Between ages of 18-65.
You may not qualify if:
- History of adverse reaction to tDCS (trans-cranial direct current stimulation).
- History of seizure activity.
- History of head injury (including neurosurgery).
- History of illness causing brain injury.
- History of other brain-related condition (such as traumatic brain injury).
- History of diagnosis with a neurological or psychiatric disorder.
- History of metal in head (outside of mouth), such as shrapnel, surgical clips, or fragments from welding or metalwork.
- History of sensitive scalp.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
Study Sites (1)
Tufts University
Boston, Massachusetts, 02111, United States
Related Publications (5)
Brunye TT, Hussey EK, Fontes EB, Ward N. Modulating Applied Task Performance via Transcranial Electrical Stimulation. Front Hum Neurosci. 2019 Apr 30;13:140. doi: 10.3389/fnhum.2019.00140. eCollection 2019.
PMID: 31114491RESULTBrunye TT, Smith AM, Horner CB, Thomas AK. Verbal long-term memory is enhanced by retrieval practice but impaired by prefrontal direct current stimulation. Brain Cogn. 2018 Dec;128:80-88. doi: 10.1016/j.bandc.2018.09.008. Epub 2018 Nov 8.
PMID: 30414699RESULTBrunye TT. Modulating Spatial Processes and Navigation via Transcranial Electrical Stimulation: A Mini Review. Front Hum Neurosci. 2018 Jan 9;11:649. doi: 10.3389/fnhum.2017.00649. eCollection 2017.
PMID: 29375346RESULTBrunye TT, Moran JM, Cantelon J, Holmes A, Eddy MD, Mahoney CR, Taylor HA. Increasing breadth of semantic associations with left frontopolar direct current brain stimulation: a role for individual differences. Neuroreport. 2015 Mar 25;26(5):296-301. doi: 10.1097/WNR.0000000000000348.
PMID: 25714417RESULTBrunye TT, Holmes A, Cantelon J, Eddy MD, Gardony AL, Mahoney CR, Taylor HA. Direct current brain stimulation enhances navigation efficiency in individuals with low spatial sense of direction. Neuroreport. 2014 Oct 22;25(15):1175-9. doi: 10.1097/WNR.0000000000000214.
PMID: 25144391RESULT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
January 11, 2019
First Posted
January 17, 2019
Study Start
April 15, 2013
Primary Completion
April 14, 2023
Study Completion
April 14, 2023
Last Updated
April 5, 2021
Record last verified: 2021-04