Cerebral Excitability and Cognitive Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-15

Study Completion Date

2023-04-14

Brief Summary

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

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Detailed Description

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Conditions

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Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Repeated-measures crossover design.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Active High-Definition Stimulation

Active high-definition stimulation of targeted brain regions involved in perception and cognition.

Group Type EXPERIMENTAL

Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems

Intervention Type OTHER

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 High-Definition Stimulation

Sham high-definition stimulation of targeted brain regions involved in perception and cognition.

Group Type SHAM_COMPARATOR

Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes