Recruiting

tDCS

Sponsor:

University of Florida

Code:

NCT05998031

Conditions

Cognitive Impairment

Cognitive Decline

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Active tDCS

Sham tDCS

Study Details

Brief summary:

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

Conditions

Cognitive Impairment

Cognitive Decline

Study ID

NCT05998031

Start date

Apr 24, 2024

Status verified date

Jun, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Active tDCS

AA 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).

placebo comparator: 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.

Interventions

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).

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 measure

  • 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. ]

Central Contacts and Locations

Central contacts

Aprinda I Queen, PhD

3522948990aimstudy@phhp.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Aprinda Indahlastari, PhD

352-294-8990aimstudy@phhp.ufl.edu

aimstudy@phhp.ufl.edu

Principal Investigator:

Aprinda I Queen, PhD

More Information

Sponsor

University of Florida

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Cognitive Aging
  • Brain Stimulation
  • functional MRI
  • Computational Modeling
  • Finite Element Method (FEM)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-26.