Skip to main content
OpenTrials
Completed

NCT Number: NCT03521089

Cathodal tDCS in MCI: A Randomized, Double-Blind, Sham-Controlled Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neurocognitive Disorders Neurocognitive Dysfunction

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female outpatients with confirmed MCI diagnosis
  • Age 55-85
  • Right handed (tested using the Edinburgh handedness inventory)
  • Total PHQ-8 of ≤ 16 which signifies no severe depression
  • All participants and/or caregivers must be able to provide informed consent

Exclusion criteria

  • Neurodegenerative disease (e.g. Parkinson's, Huntington's, Multiple Sclerosis) other than MCI
  • Previous brain lesion
  • Intracranial abnormality such as prior stroke
  • History of seizure disorder or epilepsy
  • A "true" positive response, after patient clarification, to any question on the modified TMS/tDCS Adult Safety Screen questionnaire that would impact patient safety
  • Any history of brain stimulation treatment (e.g., electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), vagal nerve therapy (VNS), deep brain stimulation (DBS))
  • Use of any investigational drug within 4 weeks
  • Cardiac pacemakers, implanted medication pumps, intracardiac lines; acute or unstable cardiac disease; intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (exception: mouth/dental work) that cannot be safely removed
  • Known or suspected pregnancy (extremely unlikely as the age range for this study is 55-85 years)

Treatment and study plan

Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001

Device

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 names: Soterix tDCS, Transcranial direct current stimulation, Non-invasive brain stimulation, Cathodal tDCS

Primary outcomes

  1. Change in Flanker Inhibitory Control and Attention Test Scores

    Time frame: Baseline, 1-month post intervention

    Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.

  2. Change in Picture Vocabulary Test Scores

    Time frame: Baseline, 1 month post intervention

    Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.

  3. Change in List Sorting Working Memory Test Scores

    Time frame: Baseline, 1 month post intervention

    Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.

  4. Change in Dimensional Change Card Sort Test

    Time frame: Baseline, 1 month post intervention

    Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.

  5. Change in Pattern Comparison Processing Speed Test Scores

    Time frame: Baseline, 1 month post intervention

    Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.

  6. Change in Picture Sequence Memory Test v2.1 Score

    Time frame: Baseline, 1 month post intervention

    Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.

  7. Change in Oral Reading Recognition Test Score

    Time frame: Baseline, 1 month post intervention

    Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Cathodal Transcranial Direct Current Stimulation (tDCS) in Mild Cognitive Impairment (MCI): A Randomized, Double-Blind, Sham-Controlled Pilot Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 11, 2018
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.