Clinical trial NCT05998031: A Mechanistic Study to Investigate tDCS and Working Memory in MCI Patients
Official title: A Mechanistic Study to Investigate tDCS and Working Memory in MCI Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Cognitive Decline
Keywords: Cognitive Aging
Brain Stimulation
functional MRI
Computational Modeling
Finite Element Method (FEM)
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-18
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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

Detailed description: The current study is a mechanistic study to evaluate working memory gains with transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control. This study is funded by a mentored career award (The University of Florida, Clinical and Translational Science Institute \[CTSI\] Pilot Award) and thus the mentors (Drs. Cohen, DeKosky, Woods, Fang) are listed as additional Principal Investigators in this study. The proposed study investigates the effects of acute (one-time) tDCS application on working memory gains (i.e., behavior and functional) by evaluating brain structure and cognitive function relationships. tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. A mechanistic, in-scanner, crossover design tDCS study (active and sham stimulation) with 2milliamps (mA) fixed dosing application will enroll 110 participants comprising 55 cognitively normal/healthy older adults and 55 older adults with MCI. The study will employ multi-modal neuroimaging (structural and functional data), person-specific computational models, and machine learning to elucidate acute tDCS effects on working memory. Change in cognitive function (i.e., working memory performance) will be quantified using working memory tasks and magnetic resonance imaging (MRI). The investigators will compare changes in working memory performance resulting from active tDCS versus sham tDCS during 2-back task compared to 0-back task.

The investigators will test the following hypotheses:

1. Acute tDCS will increase working memory performance during active tDCS and larger degree of brain atrophy seen in MCI patients will significantly decrease current intensity in stimulated brain regions.
2. Acute tDCS will significantly increase functional connectivity within the working memory network during active tDCS but not sham.

To date, no studies have examined acute tDCS application in MCI cohort and directly comparing results to cognitively healthy cohort. The present study will provide insight into mechanisms underlying tDCS application in MCI population for combating cognitive decline in a rapidly aging population in the United States. Information gathered from this study may guide future intervention strategies to combat cognitive decline and improve the quality of life of aging population.

Eligibility criteria: 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)

Primary outcomes:
measure: 2-back Working Memory Accuracy
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Aprinda I Queen, PhD
role: PRINCIPAL_INVESTIGATOR
References: