Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608316
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Intermittent Theta-burst Stimulation for Mild Cognitive Impairment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Intermittent Theta-burst Stimulation for Enhancing Dual-Task Walking Cognitive and Physical Function in Mild Cognitive Impairment a Randomized Double-Blind Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The objectives of this study are to
1 Evaluating the Impact of iTBS on Cognitive and Physical Functions The investigators will investigate the efficacy of intermittent theta burst stimulation iTBS in patients with mild cognitive impairment MCI focusing on its effects on dual-task walking abilities balance abilities and cognitive function
2 Comparing Clinical Efficacy Based on Stimulation Sites The investigators will compare the clinical efficacy of iTBS targeting the left dorsolateral prefrontal cortex DLPFC versus bilateral DLPFC stimulation This comparison aims to directly examine potential differences in therapeutic outcomes based on the site of stimulation
3 Investigating Neurophysiological Mechanisms The investigators plan to elucidate the neurophysiological mechanisms underlying the improvements in cognitive functions and dual-task walking abilities in MCI patients facilitated by iTBS This will be achieved using fNIRS neuroimaging of brain activity
1 Evaluating the Impact of iTBS on Cognitive and Physical Functions The investigators will investigate the efficacy of intermittent theta burst stimulation iTBS in patients with mild cognitive impairment MCI focusing on its effects on dual-task walking abilities balance abilities and cognitive function
2 Comparing Clinical Efficacy Based on Stimulation Sites The investigators will compare the clinical efficacy of iTBS targeting the left dorsolateral prefrontal cortex DLPFC versus bilateral DLPFC stimulation This comparison aims to directly examine potential differences in therapeutic outcomes based on the site of stimulation
3 Investigating Neurophysiological Mechanisms The investigators plan to elucidate the neurophysiological mechanisms underlying the improvements in cognitive functions and dual-task walking abilities in MCI patients facilitated by iTBS This will be achieved using fNIRS neuroimaging of brain activity
Detailed Description:
Mild cognitive impairment MCI is a syndrome characterized by cognitive decline that is greater than expected with normal aging however it is not severe enough to meet dementia criteria Accordingly MCI is considered a transitional state between normal aging and dementia with a high risk of progression to Alzheimers disease AD In MCI memory and other cognitive domains such as executive function and visuospatial skills are typically affected Furthermore people with MCI have impaired dual-task walking function decreased balance and an increased risk of falls compared to cognitively normal older adults thus affecting the ability to perform daily activities Moreover sleep disturbances such as reduced efficiency and disruptions are common in MCI which exacerbates cognitive decline and accelerates the progression to dementia
Non-invasive brain stimulation NIBS techniques have shown potential for enhancing both cognitive and functional outcomes in neuropsychiatric diseases Transcranial magnetic stimulation TMS is the most common form of NIBS which modulates cortical excitability and neuroplasticity by inducing electromagnetic pulses in targeted brain regions TMS can be delivered in various forms based on frequency and intervals Intermittent theta burst stimulation iTBS is a type of patterned TMS that mimics endogenous theta rhythms It has shown cognitive benefits in healthy populations as well as those with AD depression and other conditions but evidence regarding its efficacy in MCI is limited
While interventions like dual-task training and non-invasive brain stimulation eg tDCS have shown promise in mitigating dual-task coordination impairments research specifically focusing on the impact of iTBS on dual-task walking abilities in MCI patients remains scarce Further research is needed to explore the potential of iTBS to improve dual-task walking ability balance and fall prevention in MCI populations
Although the dorsolateral prefrontal cortex DLPFC is often targeted with NIBS due to its role in executive functions comparisons of bilateral versus unilateral left DLPFC stimulation have not been conducted in MCI Overall there is a lack of empirical evidence supporting the use of iTBS protocols to improve cognition and functional activities in MCI Elucidating the neurophysiological mechanisms underlying NIBS techniques like iTBS remains imperative
Non-invasive brain stimulation NIBS techniques have shown potential for enhancing both cognitive and functional outcomes in neuropsychiatric diseases Transcranial magnetic stimulation TMS is the most common form of NIBS which modulates cortical excitability and neuroplasticity by inducing electromagnetic pulses in targeted brain regions TMS can be delivered in various forms based on frequency and intervals Intermittent theta burst stimulation iTBS is a type of patterned TMS that mimics endogenous theta rhythms It has shown cognitive benefits in healthy populations as well as those with AD depression and other conditions but evidence regarding its efficacy in MCI is limited
While interventions like dual-task training and non-invasive brain stimulation eg tDCS have shown promise in mitigating dual-task coordination impairments research specifically focusing on the impact of iTBS on dual-task walking abilities in MCI patients remains scarce Further research is needed to explore the potential of iTBS to improve dual-task walking ability balance and fall prevention in MCI populations
Although the dorsolateral prefrontal cortex DLPFC is often targeted with NIBS due to its role in executive functions comparisons of bilateral versus unilateral left DLPFC stimulation have not been conducted in MCI Overall there is a lack of empirical evidence supporting the use of iTBS protocols to improve cognition and functional activities in MCI Elucidating the neurophysiological mechanisms underlying NIBS techniques like iTBS remains imperative
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