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

NCT05998031 | Recruiting FDA Device

• 2 other identifiers: IRB202202370K25AG086592
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 2-back Working Memory Accuracy

  N-back accuracy as working memory performance will be analyzed as a percent accuracy score on the 2-back and 0-back task.

  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.

Study Arms (2)

Active tDCS

EXPERIMENTAL

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).

Device: Active tDCS

Sham tDCS

PLACEBO COMPARATOR

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.

Device: Sham tDCS

Interventions

Active tDCS DEVICE

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).

Active tDCS

Sham tDCS DEVICE

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.

Sham tDCS

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Aprinda I Queen, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aprinda I Queen, PhD

CONTACT

3522948990; aimstudy@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A blinding code will be entered into the stimulation device to initiate the randomized stimulation condition.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will enroll in a randomized double-blinded crossover within subject study. Each participant will undergo two MRI sessions. Each MRI session will include either one active tDCS or one sham tDCS. The order of delivering active or sham tDCS first will be randomized. A washout period between active and sham tDCS will be set for at least two-weeks to ensure no after-effect from the first stimulation session will be carried over to the second session.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 18, 2023
• Study Start: April 24, 2024
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-05

Locations

US (1)