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Completed

NCT Number: NCT04246164

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Memory Disorders Memory Loss Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • Lack of study partner (Participants are allowed to find a new study partner if the original study partner withdraws)

Treatment and study plan

HD-tDCS combined with CT

Device

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

sham HD-tDCS combined with CT

Device

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

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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 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.

  2. Collect Preliminary Data on the Efficacy of MFE-HD-tDCS in Combination With Computerized CT to Improve Quality of Life in Subjects With MCI

    Time frame: Measure quality of life in subjects over a period of 3 months

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

    Time frame: 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-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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • University of Wisconsin, Madison

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2020
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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