Mild Cognitive ImpairmentminiSTIMNCT06453980
Multimodal Investigation of Neural Plasticity
A study testing active tDCS in people with Mild Cognitive Impairment, run by University of Michigan at 1 site in United States.
Trial summary
This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in cognitively intact older adults (healthy controls, HC) and in those with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal cognition for HC and diagnosis of Mild Cognitive Impairment (MCI) for MCI participants
- Right-handedness
- Magnetic resonance 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)
Who cannot join
- History of other contributing neurological or medical conditions known to affect cognitive functioning
- Significant mental illness
- Sensory impairments that limit ability to participate
- History of alcohol or drug abuse/dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Alexandru Iordan, Ph.D, 734-764-2909, adiordan@med.umich.edu
Alexandru Iordan, Ph.D
About this study
Official title: Multimodal Investigation of Neural Plasticity Induced by Non-invasive Brain Stimulation
This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in cognitively intact older adults (healthy controls, HC) and in those with mild cognitive impairment (MCI).
Read the detailed description
The goal of this study is to learn important information about the effects of weak electrical stimulation (known as high-definition transcranial direct current stimulation or HD-tDCS) on brain functioning in those with mild cognitive impairment (MCI). The findings will help determine how stimulation affects brain's activity and metabolism (in particular, the neurotransmitter glutamate). Ultimately, this information may help develop new treatments for those with Alzheimer's disease. The study will use different forms of brain imaging to see whether stimulation changes how the brain responds during a memory task. Functional magnetic resonance spectroscopy (fMRS), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS) will be used. The study also uses cognitive tests and questionnaires.
- Conditions
- Mild Cognitive Impairment
- Being tested
- sham tDCS, active tDCS
- Keywords
- tDCS, Glutamate, MRS, fMRI, fNIRS
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham tDCSDevice
Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 1 session.
active tDCSDevice
Participants will receive HD-tDCS at 3 milliAmp for 20 minutes, for 1 session.
| Study group | Role | What they receive |
|---|---|---|
| HC sham tDCS | Sham comparator | Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session. Receives: Device: sham tDCS |
| HC active tDCS | Experimental | 3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session. Receives: Device: active tDCS |
| MCI sham tDCS | Sham comparator | Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session. Receives: Device: sham tDCS |
| MCI active tDCS | Experimental | 3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session. Receives: Device: active tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glutamate concentration (fMRS)
Analyses via fMRS using units of concentration
Measured: average on 1 week
Changes in brain activation (fMRI)
Analyses via fMRI using units of brain activation
Measured: average of 1 week
Secondary outcomes (2)
Changes in memory performance
Analyses of memory performance indexed as percent accuracy
Measured: average of 1 week
Changes in brain activation (fNIRS)
Analyses via fNIRS using units of brain activation
Measured: immediate, concurrent with tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start13 May 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Healthy controls (HC) and individuals with MCI will be randomized 1:1:1:1 to receive either sham or active stimulation (i.e., HC sham tDCS, HC active tDCS, MCI sham tDCS, MCI active tDCS) for 1 session using a blocked randomization design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association, Wayne State University
- Responsible party
- Principal investigator, Alexandru Iordan, University of Michigan
- Investigators
- Alexandru Iordan, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453980
- Sponsor's protocol ID
- HUM00201483
- Acronym
- miniSTIM
- Status last verified
- Mar 2026
- First submitted
- 17 May 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Investigation of Neural Plasticity Induced by Non-invasive Brain Stimulation
- ClinicalTrials.gov ID
- NCT06453980
- Acronym / sponsor ID
- miniSTIM / HUM00201483
- Conditions
- Mild Cognitive Impairment
- Keywords
- tDCS, Glutamate, MRS, fMRI, fNIRS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Alzheimer's Association, Wayne State University
- Study start
- 13 May 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in cognitively intact older adults (healthy controls, HC) and in those with mild cognitive impairment (MCI).
Detailed description
The goal of this study is to learn important information about the effects of weak electrical stimulation (known as high-definition transcranial direct current stimulation or HD-tDCS) on brain functioning in those with mild cognitive impairment (MCI). The findings will help determine how stimulation affects brain's activity and metabolism (in particular, the neurotransmitter glutamate). Ultimately, this information may help develop new treatments for those with Alzheimer's disease. The study will use different forms of brain imaging to see whether stimulation changes how the brain responds during a memory task. Functional magnetic resonance spectroscopy (fMRS), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS) will be used. The study also uses cognitive tests and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Healthy controls (HC) and individuals with MCI will be randomized 1:1:1:1 to receive either sham or active stimulation (i.e., HC sham tDCS, HC active tDCS, MCI sham tDCS, MCI active tDCS) for 1 session using a blocked randomization design.
| Arm | Type | Receives |
|---|---|---|
| HC sham tDCS | Sham comparator | Device: sham tDCSSham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session. |
| HC active tDCS | Experimental | Device: active tDCS3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session. |
| MCI sham tDCS | Sham comparator | Device: sham tDCSSham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session. |
| MCI active tDCS | Experimental | Device: active tDCS3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal cognition for HC and diagnosis of Mild Cognitive Impairment (MCI) for MCI participants
- Right-handedness
- Magnetic resonance 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)
Key exclusion criteria (4 listed)
- History of other contributing neurological or medical conditions known to affect cognitive functioning
- Significant mental illness
- Sensory impairments that limit ability to participate
- History of alcohol or drug abuse/dependence
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 |
|---|---|---|
| sham tDCSParticipants will receive sham (placebo) HD-tDCS for 20 minutes, for 1 session. | Device | HC sham tDCS, MCI sham tDCS |
| active tDCSParticipants will receive HD-tDCS at 3 milliAmp for 20 minutes, for 1 session. | Device | HC active tDCS, MCI active tDCS |
Primary outcome
Changes in glutamate concentration (fMRS)
Time frame: average on 1 week
Analyses via fMRS using units of concentration
Changes in brain activation (fMRI)
Time frame: average of 1 week
Analyses via fMRI using units of brain activation
2 secondary outcomes
Changes in memory performance
Time frame: average of 1 week
Changes in brain activation (fNIRS)
Time frame: immediate, concurrent with tDCS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- 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.
Alexandru Iordan, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS in people with Mild Cognitive Impairment, 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 4 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: looking for participants now, as of the sponsor's last update on 10 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harini Babu, MSc (734-647-3704, hariniba@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glutamate concentration (fMRS) (time frame: average on 1 week). The study lists 2 primary outcomes in all. 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 10 Mar 2026.