Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study
Condition: Mild Cognitive Impairment; Cognitive Impairment; Neurocognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study evaluates the application of non-invasive brain stimulation in the treatment of
      Mild Cognitive Impairment (MCI) in adults aged 55-85. Half of the participants will receive
      transcranial direct current stimulation (tDCS), while the other half will receive sham (like
      placebo) stimulation.
    

Detailed description: 
      The purpose of this study is to investigate whether giving transcranial direct current
      stimulation (tDCS) treatment using an investigational device called the Soterix tES Device
      (tDCS device) on the right side of the brain can improve performance on cognitive tests.
      Investigational means that the tDCS device is not approved by the U.S. Food and Drug
      Administration (FDA) for the use in this study.

      tDCS is a non-invasive way to electrically stimulate the brain. The tDCS device is portable
      and runs on two 9-volt batteries. Electrodes from the tDCS device carry weak electrical
      current through the scalp and skull and into the brain. When the direction of the electric
      current flow is called cathodal, the brain under the site of stimulation reduces its
      activity.

      When tasks are performed, certain parts of the brain are activated. Research studies have
      shown that younger adults and older adults activate similar parts of the brain when
      performing the same task (a memory task, for example). However, other researchers found older
      adults who scored worse on memory tasks, and those with Mild Cognitive Impairment, activated
      an additional part of the brain so both sides of the brain are activated. Researchers are not
      sure whether this additional activation is helpful or not. Investigators in this study
      believe that this extra activation may be contributing to worse performance on tasks.

      It may be possible to use tDCS to reduce the brain activity on the extra activation (right)
      side in older adults, to resemble an activation pattern seen in younger adults (or higher
      scoring cohort). Using cathodal tDCS to reduce brain activity might help the brain in
      performing tasks.
    

Intervention name(s): Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001
Intervention type(s): Device
Intervention description(s): Transcranial direct current stimulation works by sending constant, low direct current through the electrodes. When these electrodes are placed in the region of interest, the current induces intracerebral current flow. This current flow then either increases or decreases the neuronal excitability in the specific area being stimulated based on which type of stimulation is being used. This change of neuronal excitability leads to alteration of brain function, which can be used in various therapies as well as to provide more information about the functioning of the human brain.
Other intervention name(s): Soterix tDCS; Transcranial direct current stimulation; Non-invasive brain stimulation; Cathodal tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized 1:1 to active or sham transcranial direct current stimulation (tDCS) intervention
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mild Cognitive Impairment (MCI); Transcranial Direct Current Stimulation (tDCS)