Actively Recruiting

Phase Not Applicable
Age: 60Years - 95Years
All Genders
Healthy Volunteers
ID05998031

A Mechanistic Study to Investigate tDCS and Working Memory in Older Adults With Mild Cognitive Impairment

Led by University of Florida · Updated on 2025-10-01

110

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, affects working memory in older adults with mild cognitive impairment (MCI) compared to cognitively healthy older adults. This mechanistic study aims to understand the brain and cognitive function changes caused by a single session of tDCS. The study uses advanced brain imaging and machine learning to analyze the effects of stimulation on brain structure and working memory performance during specific tasks. Participants will receive either active or sham tDCS using a neuroConn MR-safe device that delivers 2.0 mA current through electrodes placed on the scalp over frontal brain regions. Active stimulation lasts 12 minutes with gradual ramp-up and ramp-down, while sham stimulation mimics the sensation but only delivers current for 30 seconds. Each participant completes three runs of an N-back working memory task before, during, and after stimulation. The study uses a randomized, double-blind, crossover design with at least two weeks between sessions. Throughout the study, participants undergo cognitive testing and brain MRI scans to measure working memory accuracy and brain connectivity changes. The main outcome is working memory performance on the 2-back task comparing active versus sham stimulation. Researchers will also monitor safety and participant ability to perform the tasks and tolerate stimulation. The total participation period includes multiple sessions spaced to allow for washout and evaluation of stimulation effects, with the study concluding by late 2029.

CONDITIONS

Brief Title

A Mechanistic Study to Investigate tDCS and Working Memory in MCI Patients

Who Can Participate

Age: 60Years - 95Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 to 95 years
  • Montreal Cognitive Assessment (MoCA) score 18 or above, adjusted for education
  • Able to receive electrical stimulation
  • Ability to understand conversational speech
  • Adequate motor skills to use a computer mouse and click buttons during scanning
  • Able to participate in intervention and attend training sessions
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Contraindications for MRI (metal implants, pacemaker, defibrillator, claustrophobia, neurostimulation system)
  • Left-handed or left hand dominant
  • History of neurological, seizure, psychiatric disorders, traumatic brain injury, or stroke involving large vessels
  • Terminal illness with less than 12 months life expectancy
  • Brain tumors, malformations, or foreign objects in brain
  • Active cancer treatment except skin cancer
  • Use of certain medications that affect brain stimulation (GABAergic, glutamatergic, calcium or sodium channel blockers)
  • Severe hearing loss or speech disorders preventing communication
  • Severe sensory impairment
  • Inability to communicate in English
  • Severe visual impairment preventing assessment or intervention
  • Physical impairment preventing motor response or lying still in scanner
  • Moderate to severe depression (Geriatric Depression Scale score 10 or higher)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Single session

Participants undergo a one-time session of transcranial direct current stimulation (tDCS), either active or sham, during which they perform working memory tasks while inside an MRI scanner to evaluate brain function and cognitive performance.

1 in-person visit including MRI and stimulation

Trial Site Locations

Total: 1 location

1

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

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Research Team

A

Aprinda I Queen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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