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Recruiting NCT06453980

Multimodal Investigation of Neural Plasticity

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sham tDCS, active tDCS.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Changes in glutamate concentration (fMRS) [Time frame: average on 1 week]
  • Changes in brain activation (fMRI) [Time frame: average of 1 week]
Secondary outcome measures (2)
  • Changes in memory performance [Time frame: average of 1 week]
  • Changes in brain activation (fNIRS) [Time frame: immediate, concurrent with tDCS]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT06453980 · HUM00201483

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗