Cerebral Excitability and Cognitive Performance

April 2, 2021 updated by: Tad Brunye, Tufts University
This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 weeks
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.
36 weeks
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.
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2013

Primary Completion (Anticipated)

April 14, 2023

Study Completion (Anticipated)

April 14, 2023

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1303018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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