Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563453
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Implication of Cognitive Reserve in Non-pharmacological Intervention Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implication of Cognitive Reserve in Non-pharmacological Intervention Outcomes
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cognitive reserve CR is defined as the gradual accumulation of neural resources and their adaptability ie efficiency capacity flexibility due to genetic andor lifelong environmental factors that mitigate the cognitive effects of age-related processes and brain diseases Transcranial alternating current stimulation tACS can be used to entrain underlying neuronal networks promoting firing at specific frequencies Recent studies have demonstrated that fronto-parietal theta oscillatory activity entrainment via tACS leads to working memory enhancement in healthy subjects However there remains significant variability in stimulation-induced aftereffects across individuals
Emerging literature suggests that individual differences such as CR levels may be crucial in predicting the benefits of treatment interventions as they reflect available neural capacity and flexibility A novel interventional approach is proposed to study CR utilizing both conventional static proxies such as premorbid intellect and educational attainment and dynamic markers including pupillometry resting-state and task-induced functional MRI By employing cutting-edge noninvasive brain stimulation NIBS techniques the study will acutely modulate network properties to examine the influence of CR on immediate cognitive and brain functional aftereffects induced by the intervention In addition to focusing on cognitively healthy older adults this study will for the first time include patients with mild cognitive impairment with Lewy bodies MCI-LB a prodromal stage of the second most common degenerative dementia after Alzheimers disease
Emerging literature suggests that individual differences such as CR levels may be crucial in predicting the benefits of treatment interventions as they reflect available neural capacity and flexibility A novel interventional approach is proposed to study CR utilizing both conventional static proxies such as premorbid intellect and educational attainment and dynamic markers including pupillometry resting-state and task-induced functional MRI By employing cutting-edge noninvasive brain stimulation NIBS techniques the study will acutely modulate network properties to examine the influence of CR on immediate cognitive and brain functional aftereffects induced by the intervention In addition to focusing on cognitively healthy older adults this study will for the first time include patients with mild cognitive impairment with Lewy bodies MCI-LB a prodromal stage of the second most common degenerative dementia after Alzheimers disease
Detailed Description:
A novel interventional approach is proposed for studying cognitive reserve CR using dynamic biomarkers including
Neuromelanin-sensitive MRI sequences to evaluate signal intensity of the locus coeruleus Resting-state functional MRI rs-fMRI to evaluate network properties such as modularity and local and global efficiency Baseline dynamic rs-fMRI to evaluate mean dwell time and number of transitions between states and Baseline task-induced activation to evaluate engagement of domain-specific and domain-general regions during the offline transfer working memory WM task performance ie tasks solved after transcranial alternating current stimulation tACS
These dynamic biomarkers are used in addition to established conventional static proxies education and premorbid intellect
Specifically the study aims to
Assess which CR biomarkers and conventional CR proxies alone or in combination best predict the tACS-induced magnitude of cognitive enhancement of the online WM task solved while stimulated
Evaluate the influence of CR on the recruitment of compensatory mechanisms as assessed by task-induced fMRI and rs-fMRI induced by tACS for solving challenging WM tasks
Investigate how the CR level moderates the relationship between the magnitude and spatial patterns of brain flexibility changes induced by an acute tACS as measured by pupil dilation during the online WM task performance and pre-post tACS resting-state functional connectivity changes within and between large-scale brain networks and cognitive tACS-induced enhancement as measured by online WM task performance and changes in the offline transfer task performance solved after stimulation
Neuromelanin-sensitive MRI sequences to evaluate signal intensity of the locus coeruleus Resting-state functional MRI rs-fMRI to evaluate network properties such as modularity and local and global efficiency Baseline dynamic rs-fMRI to evaluate mean dwell time and number of transitions between states and Baseline task-induced activation to evaluate engagement of domain-specific and domain-general regions during the offline transfer working memory WM task performance ie tasks solved after transcranial alternating current stimulation tACS
These dynamic biomarkers are used in addition to established conventional static proxies education and premorbid intellect
Specifically the study aims to
Assess which CR biomarkers and conventional CR proxies alone or in combination best predict the tACS-induced magnitude of cognitive enhancement of the online WM task solved while stimulated
Evaluate the influence of CR on the recruitment of compensatory mechanisms as assessed by task-induced fMRI and rs-fMRI induced by tACS for solving challenging WM tasks
Investigate how the CR level moderates the relationship between the magnitude and spatial patterns of brain flexibility changes induced by an acute tACS as measured by pupil dilation during the online WM task performance and pre-post tACS resting-state functional connectivity changes within and between large-scale brain networks and cognitive tACS-induced enhancement as measured by online WM task performance and changes in the offline transfer task performance solved after stimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None