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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05998031
Status
Recruiting
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Conditions

  • Cognitive Decline
  • Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
60 Years - 95 Years
Healthy Volunteers
Accepted

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).
  • 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.

Study Details

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

Key Dates

Start date
Apr 24, 2024
Status verified
May 2025
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Aprinda Indahlastari, PhD
[email protected]
352-294-8990
[email protected]
Aprinda I Queen, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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