An observational study in Alzheimer Disease, Aging and MCI, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Duke University · Observational
This project is focused on the gap in understanding of bilateral brain interactions and their role in helping normative and clinical elderly populations maintain cognitive health. The investigator will focus on investigating this neural mechanism of these interactions and promoting them with a precise application of TMS, in order to test the hypothesis that excitatory interactions between the hemispheres can provide positive outcomes for patients with pre-clinical AD (amnestic Mild Cognitive Impairment or MCI-AD). In Session 1, the investigator will establish the spatial specificity of bilateral brain mechanisms with combination of behavior, TMS, and structural neuroimaging in cortical sites known to be active during memory encoding. In Session 2, the investigator will establish the underlying dynamics of interhemispheric communication using a novel combination of TMS and electroencephalography (EEG) to establish the coordinated activity between the hemispheres; Lastly, in Session 3, the investigator will use the TMS entraining parameters delineated in Aim 2 to promote specific cross-hemispheric communication, applied to participants performing a Picture Encoding task, a general task of memory performance. The outcome of these studies will allow our group to evaluate the strength of this brain stimulation protocol in alleviating age-related and dementia-related cognitive decline, and enable development of novel treatment protocols for dementia in elderly cohorts.
3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 30 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Participants will be recruited from the Duke Bryan Alzheimer's Disease Research Center Alzheimer's Disease Prevention Registry (ADRC ADPR). Thirty healthy volunteers and thirty MCI-ADs will be recruited.
Exclusion Criteria:
Subjects with a clinically defined neurological disorder including, but not limited to:
i. Multiple sclerosis.
Intracranial implants, such as:
Device: TMS
Device: TMS
A multimodal approach consisting of single pulse TMS, dual-coil TMS, and EEG will be used to examine whether synchronous hemispheric interactions associated with TMS will be present in weighted phase-lag coherence (WPLI), if these measures will be enhanced by in-phase TMS and reduced by counter-phase TMS, and if WPLI will be greater for normal controls than MCI-ADs.
Establish the structural basis for bilateral brain interactions in healthy older adults.
This will be examined using a Picture Encoding (PE) task in healthy older adults, which will allow identification of spatial brain targets based on the structural pathways connecting left and right DLPFC, ultimately relating the integrity of these pathways based on PE task performance. This Primary Outcome measure will therefore be performance scores (% correct) on this PE task.
Time frame: 2 years
Establish the structural basis for bilateral brain interactions in MCI-AD older adults.
This will be examined using a Picture Encoding (PE) task in MCI-AD participants, which will allow identification of spatial brain targets based on the structural pathways connecting left and right DLPFC, ultimately relating the integrity of these pathways based on PE task performance. This Primary Outcome measure will therefore be performance scores (% correct) on this PE task.
Time frame: 2 years
Establish the temporal dynamics of cross-hemispheric communication in normal aging using unilateral TMS
An approach consisting of single pulse will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in normal aging using bilateral TMS
An approach consisting of dual-coil TMS will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in normal aging using EEG
An approach consisting of EEG will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in MCI-AD using unilateral TMS
An approach consisting of single pulse will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in MCI-AD using bilateral TMS
An approach consisting of dual-coil TMS will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Time frame: 3 years
Establish the temporal dynamics of cross-hemispheric communication in MCI-AD using EEG
An approach consisting of EEG will be used to examine synchronous hemispheric interactions associated with TMS. The Secondary Outcome measure will be the weighted phase-lag index (WPLI), which measures the coherence between different brain regions.
Time frame: 3 years
Plan to share: Undecided
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