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Cerebral Excitability and Cognitive Performance

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ClinicalTrials.gov Identifier: NCT03807934
Recruitment Status : Enrolling by invitation
First Posted : January 17, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Tad Brunye, Tufts University

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.

Condition or disease Intervention/treatment Phase
Cognitive Change Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Repeated-measures crossover design.
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Cerebral Excitability and Cognitive Performance
Actual Study Start Date : April 15, 2013
Estimated Primary Completion Date : April 14, 2023
Estimated Study Completion Date : April 14, 2023

Arm Intervention/treatment
Experimental: Active High-Definition Stimulation
Active high-definition stimulation of targeted brain regions involved in perception and cognition.
Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems
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.

Sham Comparator: Sham High-Definition Stimulation
Sham high-definition stimulation of targeted brain regions involved in perception and cognition.
Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems
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.




Primary Outcome Measures :
  1. Visual perceptual performance [ Time Frame: 36 weeks ]
    Ability to accurately and efficiently perceive perceptual information, including threat detection, local contrast gradient detection, face memory, and intent appraisal. All are computerized tasks.

  2. Verbal cognitive performance [ Time Frame: 36 weeks ]
    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.

  3. Spatial cognitive performance [ Time Frame: 72 weeks ]
    Ability to accurately and efficiently process spatial information, including map learning, virtual urban navigation, and mental rotation. All are computerized tasks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Between ages of 18-65.

Exclusion Criteria:

  • 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.

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): NCT03807934


Locations
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United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University

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Responsible Party: Tad Brunye, PI, Tufts University
ClinicalTrials.gov Identifier: NCT03807934     History of Changes
Other Study ID Numbers: 1303018
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 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 Tad Brunye, Tufts University:
transcranial direct current stimulation
cognitive psychology
noninvasive brain stimulation
electrical brain stimulation