Multimodal Investigation of Neural Plasticity

NCT06453980 | Recruiting FDA Device

• 1 other identifier: HUM00201483
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Cognitive Impairment

Keywords

tDCS; Glutamate; MRS; fMRI; fNIRS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in memory performance

  average of 1 week

• Changes in brain activation (fNIRS)

  immediate, concurrent with tDCS

Study Arms (4)

HC sham tDCS

SHAM COMPARATOR

Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session.

Device: sham tDCS

HC active tDCS

EXPERIMENTAL

3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session.

Device: active tDCS

MCI sham tDCS

SHAM COMPARATOR

Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session.

Device: sham tDCS

MCI active tDCS

EXPERIMENTAL

3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session.

Device: active tDCS

Interventions

sham tDCS DEVICE

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

HC sham tDCS; MCI sham tDCS

active tDCS DEVICE

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

HC active tDCS; MCI active tDCS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Alzheimer's Association: collaborator
• Wayne State University: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Alexandru Iordan, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harini Babu, MSc

CONTACT

734-647-3704; hariniba@umich.edu

Eileen Robinson, RN-BC

CONTACT

734-763-1356; robinsoe@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, Medical School

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 12, 2024
• Study Start: May 13, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)