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

A Randomized, Double-Blinded, Placebo Controlled Pilot Trial of the Feasibility of High Definition Transcranial Direct Current Stimulation and Cognitive Training in Patients With Mild Cognitive Impairment.

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Memory Disorders; Memory Loss
• Intervention / Treatment: Device: HD-tDCS combined with CT; Device: sham HD-tDCS combined with CT

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥50-90 years
2. Willing and able to undergo all procedures
3. Retains decisional capacity at initial visit
4. Meets criteria for MCI, amnestic type (Petersen, 2004).

Exclusion Criteria:

1. Significant kidney injury requiring hemodialysis
2. Automatic Internal Cardiac Defibrillator (AICD) or Pacemaker
3. Significant congestive heart failure
4. History of clinically significant ischemic or hemorrhagic stroke, or lacune or infarct considered by radiologist likely to cause or contribute significantly to cognitive symptoms
5. History of thalamic lacunar stroke
6. Modified Hachinski Ischemia Score >4 points
7. History of seizure disorder requiring medication
8. History of brain surgery (for seizure disorder, aneurysms, or benign/malignant tumor)
9. History of HIV/AIDS
10. Severe untreated obstructive sleep apnea
11. Greater than three servings alcohol daily or illicit drug use
12. Major neurologic disorders other than dementia (e.g., MS, ALS)
13. Schizophrenia, bipolar disorder, other serious mental illnesses
14. Other significant medical conditions at investigators' discretion
15. Pregnancy
16. Lack of study partner (Participants are allowed to find a new study partner if the original study partner withdraws)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HD-tDCS combined with CT; HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months	Device: HD-tDCS combined with CT; HD-tDCS treatments will be administered during a cognitive training session.
Sham Comparator: sham HD-tDCS combined with CT; sham HD-tDCS combined with CT, administered to participants with amnestic MCI (aMCI) in blocks of 5 daily treatments for a total of 15 sessions. There will be one treatment block/month for a total of 3 months	Device: sham HD-tDCS combined with CT; sham-HD-tDCS treatments will be administered during a cognitive training session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the Feasibility of MFE-HD-tDCS Plus Simultaneous Computerized CT as a Viable Intervention by Measuring Consent Rates and Treatment Completion	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT	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 the sample mean. A Z-score of 0 indicates average cognitive performance compared to the reference group. For ADCS-PACC, more standard deviations above the mean generally represent a better outcome. There are not specific clinically relevant thresholds universally agreed upon for ADCS-PACC scores. Scores are typically used to compare changes over time.	Alzheimer's Disease Cooperative Study, Preclinical Alzheimer's Cognitive Composite (ADCS-PACC) score at 3 and 6 months from baseline.
Collect Preliminary Data on the Efficacy of MFE-HD-tDCS in Combination With Computerized CT to Improve Quality of Life in Subjects With MCI		Measure quality of life in subjects over a period of 3 months
Effects of MFE-HD-tDCS Combined With Computerized CT on Resting State Brain Network Connectivity	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-intervention between groups (Active versus Sham). Higher Z-scores (standard deviations above the mean) represent greater functional connectivity (stronger temporal synchronization) between the specified regions of interest (ROIs). Lower Z-scores represent reduced functional connectivity (weaker synchronization). A decrease in Z-scores (lower connectivity) is considered a better outcome.	3 months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cognitive Dysfunction; Memory Disorders
• Other Study ID Numbers: PRO00035757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No