Multimodal Investigation of Neural Plasticity

Mild Cognitive Impairment Clinical Trial

— miniSTIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453980
• Other study ID #: HUM00201483
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2024
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: Harini Babu, MSc
• Phone: 734-647-3704
• Email: hariniba[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• sham tDCS
Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 1 session.
• active tDCS
Participants will receive HD-tDCS at 3 milliAmp for 20 minutes, for 1 session.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Alzheimer's Association, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glutamate concentration (fMRS)	Analyses via fMRS using units of concentration	average on 1 week
Primary	Changes in brain activation (fMRI)	Analyses via fMRI using units of brain activation	average of 1 week
Secondary	Changes in memory performance	Analyses of memory performance indexed as percent accuracy	average of 1 week
Secondary	Changes in brain activation (fNIRS)	Analyses via fNIRS using units of brain activation	immediate, concurrent with tDCS