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

NCT04246164 | Completed Results FDA Device

• 1 other identifier: PRO00035757
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Memory Disorders; Memory Loss

Outcome Measures

Primary Outcomes (1)

• 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 In this study, 9 subjects provided informed consent. 1 subject was withdrawn. 8 subjects completed treatment.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 Outcomes (3)

• Collect Preliminary Data on the Efficacy of MFE-HD-tDCS With Simultaneous Computerized CT

  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

  3 months

Study Arms (2)

HD-tDCS combined with CT

ACTIVE COMPARATOR

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

sham HD-tDCS combined with CT

SHAM COMPARATOR

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

Interventions

HD-tDCS combined with CT DEVICE

HD-tDCS treatments will be administered during a cognitive training session.

HD-tDCS combined with CT

sham HD-tDCS combined with CT DEVICE

sham-HD-tDCS treatments will be administered during a cognitive training session.

sham HD-tDCS combined with CT

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Significant kidney injury requiring hemodialysis
• Automatic Internal Cardiac Defibrillator (AICD) or Pacemaker
• Significant congestive heart failure
• History of clinically significant ischemic or hemorrhagic stroke, or lacune or infarct considered by radiologist likely to cause or contribute significantly to cognitive symptoms
• History of thalamic lacunar stroke
• Modified Hachinski Ischemia Score \>4 points
• History of seizure disorder requiring medication
• History of brain surgery (for seizure disorder, aneurysms, or benign/malignant tumor)
• History of HIV/AIDS
• Severe untreated obstructive sleep apnea
• Greater than three servings alcohol daily or illicit drug use
• Major neurologic disorders other than dementia (e.g., MS, ALS)
• Schizophrenia, bipolar disorder, other serious mental illnesses
• Other significant medical conditions at investigators' discretion
• Pregnancy

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peter Kraegel
• Organization: Medical College of Wisconsin

pkraegel@mcw.edu

414-955-0657

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: placebo controlled

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: January 25, 2021
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: April 23, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)