Multimodal Investigation of Neural Plasticity (miniSTIM)

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).

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: sham tDCS; Device: active tDCS

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harini Babu, MSc; Phone Number: 734-647-3704; Email: hariniba@umich.edu
• Study Contact Backup: Name: Eileen Robinson, RN-BC; Phone Number: 734-763-1356; Email: robinsoe@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Alexandru Iordan, Ph.D
      • Contact: Alexandru Iordan, Ph.D; Phone Number: 734-764-2909; Email: adiordan@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: HC sham tDCS; Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session.	Device: sham tDCS; Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 1 session.
Experimental: HC active tDCS; 3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session.	Device: active tDCS; Participants will receive HD-tDCS at 3 milliAmp for 20 minutes, for 1 session.
Sham Comparator: MCI sham tDCS; Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session.	Device: sham tDCS; Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 1 session.
Experimental: MCI active tDCS; 3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session.	Device: active tDCS; Participants will receive HD-tDCS at 3 milliAmp for 20 minutes, for 1 session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in glutamate concentration (fMRS)	Analyses via fMRS using units of concentration	average on 1 week
Changes in brain activation (fMRI)	Analyses via fMRI using units of brain activation	average of 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in memory performance	Analyses of memory performance indexed as percent accuracy	average of 1 week
Changes in brain activation (fNIRS)	Analyses via fNIRS using units of brain activation	immediate, concurrent with tDCS

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Wayne State University; Alzheimer's Association
• Investigators: Principal Investigator: Alexandru Iordan, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: tDCS; fMRI; Glutamate; fNIRS; MRS
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: HUM00201483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes