NCT03521089

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

Completed NA Results posted Last updated 25 March 2020

What this trial tests

NA trial testing Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001 in Mild Cognitive Impairment in 16 participants. Completed in 31 May 2019.

Timeline

20 February 2018

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	16
Start date	20 February 2018
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Cognitive Impairment — all drugs for Cognitive Impairment →
• Neurocognitive Dysfunction — all drugs for Neurocognitive Dysfunction →

Sponsor

Mayo Clinic

Who can join

Adults 55 to 85, any sex, with Mild Cognitive Impairment or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Flanker Inhibitory Control and Attention Test Scores Primary · 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.

Group	Value	95% CI
Active tDCS	35.1	± 1.3
Sham tDCS	41.5	± 1.3

Change in Picture Vocabulary Test Scores Primary · 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.

Group	Value	95% CI
Active tDCS	52.0	± 1.2
Sham tDCS	52.0	± 1.2

Change in List Sorting Working Memory Test Scores Primary · 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.

Group	Value	95% CI
Active tDCS	60.5	± 1.9
Sham tDCS	51.8	± 1.9

Change in Dimensional Change Card Sort Test Primary · 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.

Group	Value	95% CI
Active tDCS	43.7	± 2.8
Sham tDCS	48.0	± 2.8

Change in Pattern Comparison Processing Speed Test Scores Primary · 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.

Group	Value	95% CI
Active tDCS	46.6	± 3.0
Sham tDCS	51.6	± 3.0

Change in Picture Sequence Memory Test v2.1 Score Primary · 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.

Group	Value	95% CI
Active tDCS	45.2	± 3.8
Sham tDCS	42.8	± 3.8

Change in Oral Reading Recognition Test Score Primary · 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.

Group	Value	95% CI
Active tDCS	58.5	± 1.7
Sham tDCS	56.1	± 1.7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.