Skip to main content
Clinical Trials/NCT06453980
NCT06453980
Recruiting
N/A

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

University of Michigan1 site in 1 country80 target enrollmentMay 13, 2024

Overview

Phase
N/A
Intervention
active tDCS
Conditions
Mild Cognitive Impairment
Sponsor
University of Michigan
Enrollment
80
Locations
1
Primary Endpoint
Changes in glutamate concentration (fMRS)
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 13, 2024
End Date
April 30, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexandru Iordan

Assistant Professor of Psychiatry, Medical School

University of Michigan

Eligibility Criteria

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

Arms & Interventions

MCI active tDCS

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

Intervention: active tDCS

HC sham tDCS

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

Intervention: sham tDCS

HC active tDCS

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

Intervention: active tDCS

MCI sham tDCS

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

Intervention: sham tDCS

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Changes in memory performance(average of 1 week)
  • Changes in brain activation (fNIRS)(immediate, concurrent with tDCS)

Study Sites (1)

Loading locations...

Similar Trials