Cerebral Excitability and Cognitive Performance

Study Overview
=================
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.

Official Title
-----------------
Cerebral Excitability and Cognitive Performance

Conditions
-----------------
Cognitive Change

Intervention / Treatment
-----------------
* Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Repeated-measures crossover design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active High-Definition Stimulation<br>Active high-definition stimulation of targeted brain regions involved in perception and cognition. | Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems<br>* 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.<br>|
| Sham Comparator: Sham High-Definition Stimulation<br>Sham high-definition stimulation of targeted brain regions involved in perception and cognition. | Other: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcranial direct current stimulation, cognitive psychology, noninvasive brain stimulation, electrical brain stimulation