RecruitingNot ApplicableNCT05998031

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


Sponsor

University of Florida

Enrollment

110 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 60 YearsMax Age: 95 Years

Inclusion Criteria5

  • 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

Exclusion Criteria14

  • 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)

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Interventions

DEVICEActive 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).

DEVICESham 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.


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT05998031


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