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

ConditionsCognitive Impairment Cognitive Decline

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60-95

SponsorUniversity of Florida

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

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).
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.

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: Active tDCSExperimental treatment 1 intervention

Group B: Sham tDCSPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

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