Cerebral Excitability and Cognitive Performance

Tufts University1,500 enrolled

Overview

This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

1,500

Conditions

Cognitive Change

Interventions

Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systemsOTHER

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

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tufts University

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 72 weeks

Data from ClinicalTrials.gov

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