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Mild Cognitive ImpairmentSTIMNCT03875326

Stimulation to Improve Memory

A study testing 1 mA HD-tDCS, 2 mA HD-tDCS and 3 mA HD-tDCS in people with Mild Cognitive Impairment and Dementia of Alzheimer Type, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will test the effects of different doses of a form of non-invasive brain stimulation for the treatment of individuals with mild cognitive impairment (MCI) and dementia of the Alzheimer's Type (DAT). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
1 mA HD-tDCS, 2 mA HD-tDCS and 3 mA HD-tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
233 participants
Where
1 siteUnited States
Study dates
1 Apr 2019to 19 Dec 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Mild Cognitive Impairment (MCI) or dementia of the Alzheimer's type (DAT)
  • Must be MRI compatible, criteria that also apply for High Definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head)
  • Stable on relevant medications for at least 4 weeks prior to study enrollment

Who cannot join

  • Certain neurological diseases
  • Certain psychiatric conditions
  • Severe sensory impairment

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Michigan

    Ann Arbor, Michigan, 48105

Other trials in United States

About this study

Official title: Testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) as Treatment of Mild Cognitive Impairment

This study will test the effects of different doses of a form of non-invasive brain stimulation for the treatment of individuals with mild cognitive impairment (MCI) and dementia of the Alzheimer's Type (DAT).

Read the detailed description

This research study is being done to learn important information about the effects of weak electrical stimulation on brain functioning in those with mild cognitive impairment (MCI) and dementia of the Alzheimer's type (DAT). The findings will help determine "how much" stimulation is needed to enhance memory and thinking abilities, how it affects brain functioning, and who is most likely to benefit. Ultimately, this information may guide treatment efforts for those at various stages of Alzheimer's disease. The study will use brain imaging to see whether these treatments change how participants learn and remember information. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) scans will be used. The study will also use cognitive tests and questionnaires to examine whether participants' memory (and related abilities) change because of treatment. The study will enroll participants with a diagnosis of MCI or DAT. It is expected but not required that participants will be co-enrolled in the University of Michigan Memory and Aging Project (UM-MAP; HUM00000382).

Being tested
1 mA HD-tDCS, 2 mA HD-tDCS, 3 mA HD-tDCS, Sham
Keywords
Dementia, Memory, Cognitive Rehabilitation, PET scan, fMRI, Brain Stimulation
Medical subject headings
Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1 mA HD-tDCSDevice

    Participants will receive HD-tDCS at 1 mA for 30 minutes, for between 5-30 sessions.

  • 2 mA HD-tDCSDevice

    Participants will receive HD-tDCS at 2 mA for 30 minutes, for between 5-30 sessions.

  • 3 mA HD-tDCSDevice

    Participants will receive HD-tDCS at 3 mA for 30 minutes, for between 5-30 sessions.

  • ShamDevice

    Participants will receive sham (placebo) HD-tDCS for 30 minutes, for between 5-30 sessions.

Study groups in NCT03875326
Study groupRoleWhat they receive
Sham StimulationSham comparatorSham (placebo) dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Receives: Device: Sham
1 mA Dosage StimulationExperimental1 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Receives: Device: 1 mA HD-tDCS
2 mA Dosage StimulationExperimental2 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Receives: Device: 2 mA HD-tDCS
3 mA Dosage StimulationExperimental3 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Receives: Device: 3 mA HD-tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Lateral Temporal Cortex Connectivity

    Primary outcome focuses on default mode network (DMN) between-network functional connectivity because the lateral temporal cortex is a core component of the DMN. Between-network functional connectivity is estimated from fMRI data as strength of temporal coupling between the DMN and other high-level (association) brain networks. For each participant and time point, correlation-based connectivity (Pearson r; Fisher r-to-z transformed; arbitrary units) computed between DMN regions and other regions of the association cortex defined using standard functional atlas. Higher values reflect stronger functional connectivity between DMN and other regions. A Z-score's range is infinite. Expected value is between -3 to 3. Analyses conducted separately for amyloid negative (A-) and amyloid positive (A+) participants. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Secondary outcomes (13)
  1. Self-Report of Contentment With Memory

    The Multifactorial Memory Questionnaire (MMQ) consists of three scales measuring separate aspects of metamemory. Items are rated on a 5-point Likert scale (0-4) based on the test taker's experiences over the previous two weeks.

    MMQ-Satisfaction (formerly called MMQ-Contentment) scale measures satisfaction, concern, and overall appraisal of one's own memory. Each of 18 statements is rated based on degree of agreement. The score range is 0 to 72, with higher scores indicating a higher degree of satisfaction.

    Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

  2. Self-Report of Memory Mistakes

    Multifactorial Memory Questionnaire (MMQ) Ability Score - This scale measures self-perception of everyday memory ability. Respondents rate how often they experienced each of 20 common memory mistakes over the previous two weeks. The score range is 0 to 80, with higher scores indicating better self-reported memory ability.

    Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

  3. Self-Report of Memory Strategies Used

    Multifactorial Memory Questionnaire (MMQ) Strategies Score - This scale measures the use of practical memory strategies and aids in day-to-day life. Respondents rate how often they used each of 19 memory strategies over the previous two weeks. The score range is 0 to 76, with higher scores indicating greater use of memory strategies.

    Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

  4. Change in Memory Functioning

    The Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) is a comprehensive neuropsychological battery for the evaluation of global cognition. The delayed memory section is a measure of delayed recall and recognition for verbal and visual information. It includes the subtests List Recall, List Recognition, Story Memory, and Figure Recall. Low scores on this index indicate difficulties with recognition and retrieval of information from long-term memory stores This index is composed of both auditory and visual measures; therefore, a severe deficit in language, auditory processing, or visual functioning may impact one of the measures more than the other. Analysis included the sum of the raw scores for each of the delayed memory subtests, with possible scores ranging from 0 to 62. Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

  5. Change in Overall Fluid Cognitive Abilities

    Cognitive function was determined using the NIH Toolbox-Cognition Battery computerized tests, specifically the Fluid composite score. It is derived by averaging the subtests in the Fluid domain to achieve an overall standard score. Fully Corrected T-scores are adjusted for for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.

    Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

  6. Cumulative Working Memory Effects of HD-tDCS Across Treatment Sessions

    The n-back test is a working memory task where participants identify stimulus that matches stimulus experienced "n" steps back. Participants performed a 2-back test, in which they were asked to remember and press a button when shown a stimulus that appeared 2 steps before the current one (e.g. square, circle, square).

    The number of correct and incorrect identifications are normalized (z-score). Total score is the z-score of correct button presses minus the z-score of incorrect button presses. A higher score (d') reflects better working memory performance. Possible scores range from -4.85 to 4.85. Positive change (increase) in 2-back score across treatment sessions indicates improvement in working memory performance. Data is shown as the mean slope calculation of participants across first 5 days of treatment and across all treatments, x=days of treatment, y=n-back score.

    Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

  7. Cumulative Memory Accuracy Effects of HD-tDCS Across Treatment Sessions

    Paired Associates task is a verbal memory task that asks participants to learn a list of word pairs. After a delay, participants are shown correct and mismatched word pairs one at a time and asked to identify if the displayed word pair was from the list they were asked to learn or not.

    Total accuracy is a proportion (total correct responses divided by total trials completed) ranging from 0 to 1 that measures the accuracy of a participant's responses to both correct and mismatched word pairs. Higher scores indicate better verbal memory performance, and positive changes over time indicate an improvement in verbal memory performance, measured after baseline (Session 1) and every intervention session (Sessions 2-5)

    Data is shown as the mean slope calculation of participants across first 5 days of treatment and across all treatments, x=days of treatment, y= total accuracy.

    Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

  8. Cumulative Memory Sensitivity Effects of HD-tDCS Across Daily Sessions

    Verbal memory performance for computerized Paired Associates task, summarized with a computational model (linear ballistic accumulator decision model). The model uses each participant's accuracy and reaction times across trials to estimate how efficiently they accumulate information to distinguish previously studied (target) word pairs from new (lure) pairs. Reported outcome is the average memory sensitivity score at baseline, expressed as unitless model values (scores on a scale) where higher scores indicate better discrimination, scores near zero indicate chance-level performance, and negative scores (if present) indicate performance worse than chance.

    Measured: Baseline

  9. Tolerability of HD-tDCS

    Tolerability was assessed using the HD-tDCS Safety Questionnaire, an 11-item symptom checklist. The questionnaire assesses the presence (yes/no) of 10 specific self-reported symptoms (Itching, Burning, Tingling, Scalp Pain, Trouble Concentrating, Sleep problems, Headache, Mood Change, Neck Pain, and Other symptoms) and 1 oberserved symptom, Skin Redness. Skin Redness was excluded from this analysis as it is not related to the participant's perception of tolerability. The total score (symptom burden) was calculated by summing the number of symptoms present across the 10 items for each session. Score range: 0 to 10 symptoms, where 0 = no symptoms present and 10 = all symptoms present. Higher scores indicate worse tolerability (more symptoms experienced). Values represent the mean number of symptoms per session, calculated by averaging symptom burden scores across all post-stimulation assessments within each treatment group.

    Measured: Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks); values represent mean symptom burden averaged across all post-stimulation assessments

  10. Effectiveness of Blinding of HD-tDCS

    Participant's perception of treatment assignment assessed after each stimulation session using a 3-category ordinal scale. Participants guessed whether they received: (0) Sham stimulation, (1) Don't Know, or (2) Active stimulation. The scale is ordinal with Sham < Don't Know < Active. Effective blinding is indicated by no significant difference in the distribution of perceived assignment between active and sham groups (i.e., participants in active groups cannot reliably distinguish their treatment from sham). Higher proportional odds ratios would indicate active group participants were more likely to guess "active"; lower ratios would indicate sham participants were more likely to guess "active" (paradoxical pattern suggesting convincing sham condition).

    Measured: Assessed immediately after each HD-tDCS session (participants received up to 30 sessions over approximately 1-12 weeks)

  11. Change in Default Mode Network Connectivity

    The outcome focuses on default mode network (DMN) within-network functional connectivity. Within-network functional connectivity is estimated from fMRI data as strength of temporal coupling within DMN regions (nodes). For each participant and time point, correlation-based connectivity (Pearson r; Fisher r-to-z transformed; arbitrary units) was computed between DMN regions defined using a standard functional atlas. Higher values reflect stronger functional connectivity within DMN. A Z-score's range is infinite. Expected value is around -3 to 3. Analyses are conducted separately for amyloid negative (A-) and amyloid positive (A+) participants.

    Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

  12. Cumulative Cognitive Change Across Daily Consecutive Sessions

    Measured through change in Cogstate or other comparable computerized cognitive testing scores across consecutive daily sessions.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

  13. Change in Global Cognition

    The Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) is a comprehensive neuropsychological battery for the evaluation of global cognition and has been validated in subjects with mild cognitive impairment, moderate to severe traumatic brain injuries, vascular dementias, and Alzheimer's disease. Data was analyzed using the sum of the subtest raw scores, which is an indicator of the general cognitive functioning of the examinee. Low scores suggest general cognitive impairment even when some individual subtest scores may be within normal limits. Individuals with low scores on this measure exhibit problems with attention, memory, language, and construction skills. Possible scores range from 0 to 321.

    Post Intervention data collection was on day 5 of treatment. Post-Expansion (PE) appointments were not consecutive. Mean time between enrollment and PE was 10 wks, longest was 43 wks.

    Measured: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2019
  2. Study start1 Apr 2019
  3. Primary completion6 Dec 2024
  4. Study completion19 Dec 2024

Resources

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
Eligible participants will be randomized 1:1:1:1 to receive either sham, 1mA, 2mA, or 3mA HD-tDCS for at least 5 sessions and up to 30 sessions using a blocked randomization design.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03875326
Sponsor's protocol ID
HUM00146180
Other IDs
1R01AG058724
Acronym
STIM
Status last verified
Jun 2026
First submitted
11 Mar 2019
Last updated
2 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 1 mA HD-tDCS, 2 mA HD-tDCS and 3 mA HD-tDCS in people with Mild Cognitive Impairment and Dementia of Alzheimer Type, run by University of Michigan 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 3 inclusion and 3 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 2 Jul 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 2 Jul 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?

Change in Lateral Temporal Cortex Connectivity (time frame: Change from Baseline to Post-Intervention (after tDCS Session 5 - day 5 of treatment) and from Baseline to Post-Expansion (after the participant's final tDCS session beyond Session 5, up to 43 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Jul 2026.

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