Neuromodulation Effects in Older Adults
- Conditions
- Cognitive ImpairmentCognitive Decline
- Registration Number
- NCT06665022
- Lead Sponsor
- University of Florida
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 2-back Working Memory Accuracy 12 minutes versus 24 minutes in each session. Then comparing active versus sham stimulation sessions, separated by at least two weeks. The descriptive name of the scale is 2-back Working Memory Accuracy. Participants will perform in-scanner 0 and 2-back (i.e., N-back) working memory task that asks them to acknowledge whether a letter was the same as the letter 2 or N times before. Participant will view one letter at a time, with a crosshair appear briefly as an inter-stimulus interval. The task paradigm for each run consists of four blocks of 2-back and four blocks of 0-back. Two runs (before and during stimulation) will be performed at each visit.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States