Clinical trial NCT06453980: Multimodal Investigation of Neural Plasticity
Official title: Multimodal Investigation of Neural Plasticity Induced by Non-invasive Brain Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: tDCS
Glutamate
MRS
fMRI
fNIRS
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
name: Wayne State University
First posted: 2024-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in glutamate concentration (fMRS)
timeFrame: average on 1 week
measure: Changes in brain activation (fMRI)
timeFrame: average of 1 week
Secondary outcomes:
measure: Changes in memory performance
timeFrame: average of 1 week
measure: Changes in brain activation (fNIRS)
timeFrame: immediate, concurrent with tDCS
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alexandru Iordan, PhD
role: PRINCIPAL_INVESTIGATOR
References: