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

NCT ID: NCT04246164

Last Updated: 2026-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2023-02-23

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment Memory Disorders Memory Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
double-blinded

Study Groups

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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

Group Type ACTIVE_COMPARATOR

HD-tDCS combined with CT

Intervention Type DEVICE

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

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

Group Type SHAM_COMPARATOR

sham HD-tDCS combined with CT

Intervention Type DEVICE

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

Interventions

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HD-tDCS combined with CT

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

Intervention Type DEVICE

sham HD-tDCS combined with CT

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Priyanka Shah-Basak, PhD

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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PRO00035757

Identifier Type: -

Identifier Source: org_study_id

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