NCT05998031 · University of Florida
A Mechanistic Study to Investigate tDCS and Working Memory in MCI Patients
(AIM)
What this study is about
The current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control
View original scientific description
The current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control
Interventions
DEVICE
Active tDCS
A neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode).
DEVICE
Sham tDCS
Sham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform three runs of N-back working memory task (baseline/pre-stimulation, during stimulation, and after/post-stimulation) as detailed below. Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.
Primary outcome measures
2-back Working Memory Accuracy
Time frame: 12 minutes versus 24 minutes, 12 minutes versus 36 minutes. Then at each time point comparing active versus sham stimulation, separated by at least two weeks.
N-back accuracy as working memory performance will be analyzed as a percent accuracy score on the 2-back and 0-back task.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 60-95 years
- Montreal Cognitive Assessment (MoCA) score 18 and above (scores will be adjusted for education)
- Able to receive electrical stimulation
- Ability to comprehend conversational voices
- Adequate motor capacity to operate computer mouse and click-button in-scanner
- Ability to participate in the intervention and attend training sessions
Exclusion criteria
- Failure to provide informed consent
- Contraindications to MRI recording (e.g., any kind of ferrous metallic stents or ferrous metal objects in the body, heart valve prosthesis, or other metal implants, claustrophobia, neurostimulation system, defibrillator, pacemaker, or other implanted device)
- Left-handed, or left hand dominant
- History of neurological, seizures, and psychiatric disorders, traumatic brain injury, incidence of stroke involving large vessel
- Terminal illness with life expectancy less than 12 months, as determined by physician
- Brain tumor or malformation or any foreign body known or previously identified in brain
- Cancer in active treatment, besides skin cancer
- Currently on GABAergic or glutamatergic medications, or on calcium or sodium channel blockers, which alter or block the ability of tDCS to facilitate tissue excitability
- Unable to communicate because of severe hearing loss or speech disorder
- Severe sensory impairment
- Inability to communicate in English
- Severe visual impairment, which would preclude completion of the assessment and/or intervention
- No physical impairment precluding motor response or lying still for an hour in the scanner that could confound study findings
- Moderate-to-severe depressive symptoms as defined by scoring 10 or above on the Geriatric Depression Scale (GDS)
Where
- Gainesville, Florida
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations