Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517043
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Spinal Networks of Balance Learning and Retention in Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Upregulating Spinal Circuits to Enhance Balance and Walking and to Increase Spinal Excitability in Older Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Age-related balance and walking issues increase fall risks leading to injuries higher healthcare costs reduced quality of life and increased morbiditymortality rates Preserving functional ability is a crucial public health priority with the potential to reduce healthcare costs and enhance older adults quality of life Declines in balance and walking ability threaten independence These declines are attributed to spinal network impairments and may be mitigated by targeted interventions aimed at addressing age-related spinal cord impairment to enhance functional outcomes However there is a lack of research into how the aging spinal cord affects balancewalking In older adults the spinal cord is less excitable conducts signals more slowly and is subject to neural noise Intervening on age-related impairment of the spinal cord to improve balancewalking ability is a very promising but untapped area of research A therapeutic approach that combines dynamic balance training with non-invasive electrical spinal stimulation may be effective in preserving functional abilities This study tests whether electrical stimulation of the spinal lumbar regions is more beneficial than sham stimulation
Detailed Description:
A high proportion of older adults are currently or soon will be at risk for the well-known decline in walking and balance abilities that occur with aging Preserving those abilities has become a major public health priority Balance training can enhance functional abilities or attenuate functional decline however age-related motor deficits may impair practice-based motor learning and behavioral performance Due to the crucial roles of the spinal cord in balance and walking performance it is important to consider that age-related neural impairment of the spinal cord is a likely contributing factor Specifically the spinal cord in older adults has fewer neurons is less excitable and conducts signals more slowly
Despite ample evidence of impaired spinal cord neuronal structure and function with aging the potential benefit of an intervention targeting spinal control of balance and walking control has been largely unexplored This dearth of research may be due in part to the lack of a clinically feasible intervention However the recent emergence of transcutaneous spinal direct current stimulation tsDCS as a non-invasive intervention creates new opportunities for understanding spinal cord contributions to balance and walking performance Notably our previous study was the first demonstration of the safety and feasibility of a lab-based intervention that combined tsDCS with complex walking practice These initial findings support the enhanced efficacy of locomotor learning during a single session when combined with tsDCS in older adults Building on the success of this preliminary data the investigators now propose an extended multisession intervention that combines tsDCS with balance training The proposed study will be among the first multi-session trial to investigate the effects of tsDCS as an adjunct therapy to dynamic balance training in older adults
This study aims to enroll 30 older adults aged 65 years or older with balance or walking deficits determined through objective assessments All participants will undergo the same five-session balance training over a 2-week period which will emphasize the use of a unique balance exergaming device called the Dividat Senso Participants will be randomly assigned to a tsDCS adjuvant group The Active group will receive 30 continuous minutes of 25-mA tsDCS over lumbar regions T11T12 The Sham group will receive the sham protocol which involves an identical montage and stimulation arrangement but delivers no current for 27 minutes Each 30-minutes session will be preceded and followed by balance and walking assessments to examine the interventions effects over time Spinal excitability measured via soleus H-reflex testing will be assessed immediately before and after tsDCS at the first and last intervention Behavioral assessments will occur at baseline 1 day post-intervention and 10-day post-intervention to investigate pre vs post effects and retention intervention effects Prefrontal activity will be measured using functional near-infrared spectroscopy fNIRS during the behavioral assessments to evaluate demand on executive control networks
The objective of using tsDCS is to upregulate spinal circuits to make them more responsive to task-specific activation thereby fostering more robust learning and consolidation to enhance performance in dynamic balance tasks Thus the overarching hypothesis of the proposed research is that tsDCS will be a potent adjuvant therapy to a dynamic balance intervention by reinforcing task-appropriate spinal excitation to promote skill acquisition and retention thereby improving balance and walking This study will focus on achieving the following specific aims
Specific Aim 1 Acquire preliminary effect size and response variance data to assess whether active adjuvant tsDCS therapy combined with dynamic balance training enhances practice-related gains in balance and walking performance and retention over time
Specific Aim 2 Establish evidence of increased spinal excitability following tsDCS positively correlating with gains in balance and walking functions
The long term deliverable of this line of research will be a clinically feasible multi-modal intervention to assist in preserving motor function and independence in older adults The knowledge and experience gained from this study will enable us to conduct larger studies to better understand the effects of aging on the spinal cord and to test rehabilitation interventions to promote healthy aging among older adults
Despite ample evidence of impaired spinal cord neuronal structure and function with aging the potential benefit of an intervention targeting spinal control of balance and walking control has been largely unexplored This dearth of research may be due in part to the lack of a clinically feasible intervention However the recent emergence of transcutaneous spinal direct current stimulation tsDCS as a non-invasive intervention creates new opportunities for understanding spinal cord contributions to balance and walking performance Notably our previous study was the first demonstration of the safety and feasibility of a lab-based intervention that combined tsDCS with complex walking practice These initial findings support the enhanced efficacy of locomotor learning during a single session when combined with tsDCS in older adults Building on the success of this preliminary data the investigators now propose an extended multisession intervention that combines tsDCS with balance training The proposed study will be among the first multi-session trial to investigate the effects of tsDCS as an adjunct therapy to dynamic balance training in older adults
This study aims to enroll 30 older adults aged 65 years or older with balance or walking deficits determined through objective assessments All participants will undergo the same five-session balance training over a 2-week period which will emphasize the use of a unique balance exergaming device called the Dividat Senso Participants will be randomly assigned to a tsDCS adjuvant group The Active group will receive 30 continuous minutes of 25-mA tsDCS over lumbar regions T11T12 The Sham group will receive the sham protocol which involves an identical montage and stimulation arrangement but delivers no current for 27 minutes Each 30-minutes session will be preceded and followed by balance and walking assessments to examine the interventions effects over time Spinal excitability measured via soleus H-reflex testing will be assessed immediately before and after tsDCS at the first and last intervention Behavioral assessments will occur at baseline 1 day post-intervention and 10-day post-intervention to investigate pre vs post effects and retention intervention effects Prefrontal activity will be measured using functional near-infrared spectroscopy fNIRS during the behavioral assessments to evaluate demand on executive control networks
The objective of using tsDCS is to upregulate spinal circuits to make them more responsive to task-specific activation thereby fostering more robust learning and consolidation to enhance performance in dynamic balance tasks Thus the overarching hypothesis of the proposed research is that tsDCS will be a potent adjuvant therapy to a dynamic balance intervention by reinforcing task-appropriate spinal excitation to promote skill acquisition and retention thereby improving balance and walking This study will focus on achieving the following specific aims
Specific Aim 1 Acquire preliminary effect size and response variance data to assess whether active adjuvant tsDCS therapy combined with dynamic balance training enhances practice-related gains in balance and walking performance and retention over time
Specific Aim 2 Establish evidence of increased spinal excitability following tsDCS positively correlating with gains in balance and walking functions
The long term deliverable of this line of research will be a clinically feasible multi-modal intervention to assist in preserving motor function and independence in older adults The knowledge and experience gained from this study will enable us to conduct larger studies to better understand the effects of aging on the spinal cord and to test rehabilitation interventions to promote healthy aging among older adults
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