NCT04246164

A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI

Completed NA Results posted Last updated 28 January 2026

What this trial tests

NA trial testing HD-tDCS combined with CT in Mild Cognitive Impairment in 8 participants. Completed in 23 February 2023.

Timeline

25 January 2021

Primary endpoint
23 February 2023

23 February 2023

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	8
Start date	25 January 2021
Primary completion	23 February 2023
Estimated completion	23 February 2023
Sites	1 location across United States

Drugs / interventions tested

• HD-tDCS combined with CT
• sham HD-tDCS combined with CT

Conditions studied

• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Memory Disorders — all drugs for Memory Disorders →
• Memory Loss — all drugs for Memory Loss →

Sponsor

Medical College of Wisconsin

Who can join

Adults 50 to 90, any sex, with Mild Cognitive Impairment or Memory Disorders. 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.

Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion Primary · 6 months

This measure assesses consent rates and treatment completion amongst subjects by assessing the number of subjects who signed consent forms and the number of completed study visits. In this study, 9 subjects provided informed consent. 1 subject was withdrawn. 8 subjects completed treatment. Therefore, only the data from the 8 subjects who completed treatment were analyzed.

Number of subjects who signed consent forms

Group	Value	95% CI
HD-tDCS Combined With CT	4
Sham HD-tDCS Combined With CT	4

Number of subjects who completed study treatment

Group	Value	95% CI
HD-tDCS Combined With CT	4
Sham HD-tDCS Combined With CT	4

Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT Secondary · Alzheimer's Disease Cooperative Study, Preclinical Alzheimer's Cognitive Composite (ADCS-PACC) score at 3 and 6 months from baseline.

Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC) is a composite of 4 measures with well-established sensitivity for the detection of cognitive decline in prodromal and mild dementia. It is calculated by summing the standardized z-scores of each of the following: * Rey Auditory Verbal Learning Test (0-48 points), Logical Memory IIa sub-test from the Wechsler Memory test (0-25 points) * Mini Mental Status Examination (0-30 points) * Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale-Revised (0-93 points) Z-score of 0 represents

Mean ADCS-PACC at Baseline

Group	Value	95% CI
HD-tDCS Combined With CT	-0.95975	± 2.2504557131094
Sham HD-tDCS Combined With CT	0.85375	± 3.3297438715313

Mean ADCS-PACC at Month 3

Group	Value	95% CI
HD-tDCS Combined With CT	-0.795	± 2.5196990561044
Sham HD-tDCS Combined With CT	1.596	± 3.2651291960146

Mean ADCS-PACC at Month 6

Group	Value	95% CI
HD-tDCS Combined With CT	-0.38575	± 3.5756851441367
Sham HD-tDCS Combined With CT	1.227	± 2.764333011777

Collect Preliminary Data on the Efficacy of MFE-HD-tDCS in Combination With Computerized CT to Improve Quality of Life in Subjects With MCI Secondary · Measure quality of life in subjects over a period of 3 months

Group	Value	95% CI
HD-tDCS Combined With CT	0
Sham HD-tDCS Combined With CT	0

Effects of MFE-HD-tDCS Combined With Computerized CT on Resting State Brain Network Connectivity Secondary · 3 months

To report the correlation between activation in different brain regions reported. The clinical significance of increasing or reducing connectivity remains unclear. For example, increased connectivity could lead to strengthening of a hypo-functioning network, but reducing connectivity could also be the result of normalizing aberrant and/or compensatory hypo-connectivity. Calculation details: Pearson r correlation coefficients were computed and transformed to Fisher-z. Independent t-test or Wilcoxon Rank Sum analyses were conducted to investigate changes in connectivity from pre- to post-inte

Resting state connectivity changes between left caudal hippocampus and left lateral parietal cortex

Group	Value	95% CI
HD-tDCS Combined With CT	-0.09065	± 0.018280796
Sham HD-tDCS Combined With CT	0.12688	± 0.046184866

Resting state connectivity changes between right intraparietal sulcus and right frontal eye fields

Group	Value	95% CI
HD-tDCS Combined With CT	-0.0989	± 0.081790097
Sham HD-tDCS Combined With CT	0.11118	± 0.046729989

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were monitored recorded from the time of informed consent through study completion, an average of 6 months per subject.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HD-tDCS Combined With CT

Serious: 0/4 (0%)

Deaths: 0/4

Sham HD-tDCS Combined With CT

Serious: 1/4 (25%)

Deaths: 0/4

Serious adverse events (2 terms)

Reaction	System	HD-tDCS Combined With CT	Sham HD-tDCS Combined With…
Gallbladder removal	Surgical and medical procedures	—	—
Gall stones	Gastrointestinal disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	HD-tDCS Combined With CT	Sham HD-tDCS Combined With…
Common cold	Respiratory, thoracic and mediastinal disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Headache	General disorders	—	—

Most-reported serious reactions: Gallbladder removal, Gall stones.

Data from ClinicalTrials.gov NCT04246164 adverse events section.

Sponsor's own description

The primary objective of this project is to assess the feasibility of multi-field, extended HD-tDCS (MFE-HD-tDCS) with simultaneous computerized CT as a viable intervention to improve cognitive function in patients with MCI. This double-blinded, randomized pilot clinical trial of repetitive daily HD-tDCS/sham HD-tDCS, administered in combination with CT to subjects with MCI in 3 monthly blocks of 5 daily sessions for a total of 15 sessions will enroll 8 participants.

Publications & conference data

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