Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
Accelerated Intermittent Theta-burst Stimulation to Modify Cognitive Function and Balance in Dementia and Memory Loss
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Accelerated Intermittent Theta-burst Stimulation to Modify Cognitive Function and Balance in Dementia and Memory Loss
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The process of aging is accompanied by normal deterioration of body systems leading to a decline in various functional domains including cognitive visual vestibular somatosensory and motor function With this functional decline there is an increasing burden of care due to the rise of injury direct and indirect healthcare costs and the loss of independence in performing daily activities Notably falls in the older population represents one of the greatest costs incurred by Canadians annually
The study investigates whether rTMS delivered to M1 will lead to greater improvement in balance compared to rTMS delivered to DLPFC Determining this answer will allow greater success in TMS target refinement Given the profound burden that geriatric medicine has on the Canadian healthcare system understanding the link between balance and cognition can significantly impact the approach to management of this population
The study investigates whether rTMS delivered to M1 will lead to greater improvement in balance compared to rTMS delivered to DLPFC Determining this answer will allow greater success in TMS target refinement Given the profound burden that geriatric medicine has on the Canadian healthcare system understanding the link between balance and cognition can significantly impact the approach to management of this population
Detailed Description:
Approximately 20-30 of Canadian adults 65 years old experience falls each year and this rate drastically increases for those 85 years of age 2 With the aging population the number of annual reported falls has increased by 47 from 2008 to 2020 3 Individuals with cognitive impairment exhibit an 8x higher risk of falls compared to those without 4 Balance is a key risk factor for falls 5-7 and there is evidence suggesting that balance control is a marker of cognitive decline 8 For example cognitive function is significantly correlated with postural control 9 and postural sway 10 In Parkinsons disease balance has been linked to greater executive dysfunction and slower processing speed 11
Synaptic plasticity induced via neuromodulatory techniques can lead to improvements in motor and cognitive function One such technique is Transcranial magnetic stimulation TMS a non-invasive form of neuromodulation To induce synaptic plasticity magnetic stimuli are delivered via TMS in theta-burst patterns This includes continuous theta burst stimulation cTBS that induces long term depression LTD-like changes in neuronal excitability and intermittent theta burst stimulation iTBS that induces long term potentiation LTP-like changes in neuronal excitability 12 Previous literature suggests that iTBS may be an effective tool for modulating cognition and motor function
Wu et al 2022 found an improvement in memory function of Alzheimer disease patients following a 14-day course of iTBS delivered to the dorsolateral prefrontal cortex DLPFC 13 Trung et al 2019 showed that 3 days of iTBS delivered to the DLPFC led to cognitive improvements in a sample of Parkinsons disease patients with mild cognitive impairment MCI 14 Regarding balance iTBS has been shown to be an effective intervention for balance recovery when delivered to the cerebellum 1617 or the primary motor cortex M1 16 Improvements in gait performance have also been seen following other patterns of stimulation including repetitive TMS rTMS in the post-stroke population 18-20 These improvements in cognition and balance following iTBS may be linked to plastic changes in neuronal structure as seen in animal models 21
Accelerated intermittent theta-burst stimulation iTBS encompass multiple sessions of iTBS administered within a singular day over the course of several days consequently diminishing the duration of the treatment regimen aiTBS has been shown to be a tolerable and safe form of non-invasive brain stimulation with rapid antidepressant efficacy and anti-suicidal effects in patients with major depressive disorder 22-27 Previous studies have demonstrated aiTBS paradigm which consisted of iTBS delivered 3 times per day separated by 15 min intervals over the course of 14 days resulted in an improvement in memory function in individuals with Alzheimer disease 13 27
For this study question we have chosen two different stimulation sites DLFPC is known for its contributions to learning and memory Individuals with dementia typically receive rTMS stimulation to DLPFC to explore whether cognitive function can be improved Wu et al 2020 It has been seen that individuals with dementia suffer from a greater number of falls it is unclear whether rTMS to DLPFC will improve balance performance and risk of falls better than rTMS delivered to M1 a typical site of stimulation for balance related studies iTBS has been shown to be an effective intervention for balance recovery when delivered to the primary motor cortex M1 Liao et al 2024 Improvements in gait performance have also been seen following other patterns of stimulation including repetitive TMS rTMS in the post-stroke population when delivered to M1 Wang et al 2012 Wang et al 2019 Rastgoo et al 2016 These improvements in cognition and balance following iTBS may be linked to plastic changes in neuronal structure as seen in animal models Tsang et al 2021
We there ask the study question whether rTMS delivered to M1 will lead to greater improvement in balance compared to rTMS delivered to DLPFC Determining this answer will allow greater success in TMS target refinement Given the profound burden that geriatric medicine has on the Canadian healthcare system understanding the link between balance and cognition can significantly impact the approach to management of this population
Synaptic plasticity induced via neuromodulatory techniques can lead to improvements in motor and cognitive function One such technique is Transcranial magnetic stimulation TMS a non-invasive form of neuromodulation To induce synaptic plasticity magnetic stimuli are delivered via TMS in theta-burst patterns This includes continuous theta burst stimulation cTBS that induces long term depression LTD-like changes in neuronal excitability and intermittent theta burst stimulation iTBS that induces long term potentiation LTP-like changes in neuronal excitability 12 Previous literature suggests that iTBS may be an effective tool for modulating cognition and motor function
Wu et al 2022 found an improvement in memory function of Alzheimer disease patients following a 14-day course of iTBS delivered to the dorsolateral prefrontal cortex DLPFC 13 Trung et al 2019 showed that 3 days of iTBS delivered to the DLPFC led to cognitive improvements in a sample of Parkinsons disease patients with mild cognitive impairment MCI 14 Regarding balance iTBS has been shown to be an effective intervention for balance recovery when delivered to the cerebellum 1617 or the primary motor cortex M1 16 Improvements in gait performance have also been seen following other patterns of stimulation including repetitive TMS rTMS in the post-stroke population 18-20 These improvements in cognition and balance following iTBS may be linked to plastic changes in neuronal structure as seen in animal models 21
Accelerated intermittent theta-burst stimulation iTBS encompass multiple sessions of iTBS administered within a singular day over the course of several days consequently diminishing the duration of the treatment regimen aiTBS has been shown to be a tolerable and safe form of non-invasive brain stimulation with rapid antidepressant efficacy and anti-suicidal effects in patients with major depressive disorder 22-27 Previous studies have demonstrated aiTBS paradigm which consisted of iTBS delivered 3 times per day separated by 15 min intervals over the course of 14 days resulted in an improvement in memory function in individuals with Alzheimer disease 13 27
For this study question we have chosen two different stimulation sites DLFPC is known for its contributions to learning and memory Individuals with dementia typically receive rTMS stimulation to DLPFC to explore whether cognitive function can be improved Wu et al 2020 It has been seen that individuals with dementia suffer from a greater number of falls it is unclear whether rTMS to DLPFC will improve balance performance and risk of falls better than rTMS delivered to M1 a typical site of stimulation for balance related studies iTBS has been shown to be an effective intervention for balance recovery when delivered to the primary motor cortex M1 Liao et al 2024 Improvements in gait performance have also been seen following other patterns of stimulation including repetitive TMS rTMS in the post-stroke population when delivered to M1 Wang et al 2012 Wang et al 2019 Rastgoo et al 2016 These improvements in cognition and balance following iTBS may be linked to plastic changes in neuronal structure as seen in animal models Tsang et al 2021
We there ask the study question whether rTMS delivered to M1 will lead to greater improvement in balance compared to rTMS delivered to DLPFC Determining this answer will allow greater success in TMS target refinement Given the profound burden that geriatric medicine has on the Canadian healthcare system understanding the link between balance and cognition can significantly impact the approach to management of this population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None