Mild Cognitive ImpairmentNCT04246164
A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI
A study testing HD-tDCS combined with CT in people with Mild Cognitive Impairment and Memory Disorders, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Memory Disorders, Memory Loss
- What is being tested?
- HD-tDCS combined with CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official 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.
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
- Being tested
- HD-tDCS combined with CT, sham HD-tDCS combined with CT
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCS combined with CTDevice
HD-tDCS treatments will be administered during a cognitive training session.
sham HD-tDCS combined with CTDevice
sham-HD-tDCS treatments will be administered during a cognitive training session.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: sham HD-tDCS combined with CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start25 Jan 2021
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Principal investigator, Priyanka Shah-Basak, PhD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246164
- Sponsor's protocol ID
- PRO00035757
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2020
- Last updated
- 23 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Granadillo E, Peterson A, Bloyer E, Hancock LM, Shah-Basak P, Kraegel P, Schold S, Okonkwo O, Nair VA, Prabhakaran V, Ikonomidou C. Multifield extended high-definition transcranial direct current stimulation in mild cognitive impairment: A proof-of-concept study on cognition and brain network connectivity. J Alzheimers Dis Rep. 2026 May 22;10:25424823261449802. doi: 10.1177/25424823261449802. eCollection 2026 Jan-Dec.
PubMed 42877391
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04246164
- Acronym / sponsor ID
- PRO00035757
- Conditions
- Mild Cognitive Impairment, Memory Disorders, Memory Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo controlled
| Arm | Type | Receives |
|---|---|---|
| HD-tDCS combined with CT | Active comparator | Device: HD-tDCS combined with CTHD-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 |
| sham HD-tDCS combined with CT | Sham comparator | Device: sham HD-tDCS combined with CTsham 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 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD-tDCS combined with CTHD-tDCS treatments will be administered during a cognitive training session. | Device | HD-tDCS combined with CT |
| sham HD-tDCS combined with CTsham-HD-tDCS treatments will be administered during a cognitive training session. | Device | sham HD-tDCS combined with CT |
Primary outcome
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.
3 secondary outcomes
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.
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
Effects of MFE-HD-tDCS Combined With Computerized CT on Resting State Brain Network Connectivity
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42877391Granadillo E, Peterson A, Bloyer E, Hancock LM, Shah-Basak P, Kraegel P, Schold S, Okonkwo O, Nair VA, Prabhakaran V, Ikonomidou C. Multifield extended high-definition transcranial direct current stimulation in mild cognitive impairment: A proof-of-concept study on cognition and brain network connectivity. J Alzheimers Dis Rep. 2026 May 22;10:25424823261449802. doi: 10.1177/25424823261449802. eCollection 2026 Jan-Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-tDCS combined with CT in people with Mild Cognitive Impairment and Memory Disorders, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04246164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.