Clinical trial NCT06665022: Neuromodulation Effects in Older Adults
Official title: Neuromodulation Effects in Older Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
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
First posted: 2024-10-30
Enrollment: 0
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. 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.

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
* Adequate motor capacity to participate in intervention and training sessions

Exclusion Criteria:

* Contraindications to MRI recording
* Left-handed
* Inability to communicate in English
* History of neurological/psychiatric disorders and traumatic brain injury
* Incidence of stroke
* Severe visual and hearing impairment precluding completion of study assessments

Primary outcomes:
measure: 2-back Working Memory Accuracy
timeFrame: 12 minutes versus 24 minutes in each session. Then comparing active versus sham stimulation sessions, 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: