Skip to content

Multimodal Investigation of Neural Plasticity

Multimodal Investigation of Neural Plasticity Induced by Non-invasive Brain Stimulation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06453980
Acronym
miniSTIM
Enrollment
80
Registered
2024-06-12
Start date
2024-05-13
Completion date
2026-04-30
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

tDCS, Glutamate, MRS, fMRI, fNIRS

Brief 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).

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.

Interventions

DEVICEsham tDCS

Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 1 session.

DEVICEactive tDCS

Participants will receive HD-tDCS at 3 milliAmp for 20 minutes, for 1 session.

Sponsors

University of Michigan
Lead SponsorOTHER
Alzheimer's Association
CollaboratorOTHER
Wayne State University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in glutamate concentration (fMRS)average on 1 weekAnalyses via fMRS using units of concentration
Changes in brain activation (fMRI)average of 1 weekAnalyses via fMRI using units of brain activation

Secondary

MeasureTime frameDescription
Changes in brain activation (fNIRS)immediate, concurrent with tDCSAnalyses via fNIRS using units of brain activation
Changes in memory performanceaverage of 1 weekAnalyses of memory performance indexed as percent accuracy

Countries

United States

Contacts

CONTACTHarini Babu, MSc
hariniba@umich.edu734-647-3704
CONTACTEileen Robinson, RN-BC
robinsoe@med.umich.edu734-763-1356
PRINCIPAL_INVESTIGATORAlexandru Iordan, PhD

University of Michigan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026