Ignite Creation Date:
2024-05-06 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03512041
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2018-04-18
Brief Title:
Effect of Number of Remote Limb Ischemic Conditioning Cycles on Learning Enhancement
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Effect of Number of Remote Limb Ischemic Conditioning Cycles on Learning Enhancement in Healthy Young Adults
Status:
COMPLETED
Status Verified Date:
2019-08
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:
RLICC
Brief Summary:
The purpose of this research study is to determine the effect of number of remote limb ischemic conditioning RLIC cycles on enhancing learning in neurologically intact young adults
Detailed Description:
It is now understood that the nervous system has remarkable adaptive capacity Specifically the central nervous system retains its ability to reorganize in structure and function in response to behavioral experience in neurologically intact people and in individuals with neurological injury Cognitive and motor learning guide the adaptation of the central nervous system and are essential components of effective training paradigms
There is a growing body of literature which suggests that inducing a transient state of systemic ischemia has the potential to induce spinal plasticity strengthen spared pathways to motorneurons and lead to improved motor recovery following neurological injury12 Specifically daily systemic ischemic conditioning has been shown to improve both forelimb and respiratory motor function in rodent models of chronic cervical spinal injury13 Moreover systemic ischemic conditioning resulted in increased ankle strength single session2 and augmented walking speed and endurance 5 sessions4 in humans with motor incomplete spinal cord injuries
In a related area of research it has been shown that ischemic conditioning administered peripherally represents a strategy for harnessing the bodys endogenous protective capabilities against lethal levels of ischemia With this technique applying brief ischemia and reperfusion to a remote organ or tissue results in significantly reduced damage from subsequent exposures to ischemia For example applying a tourniquet and creating hypoxia in a rats hindlimb for 10 minutes reduced the extent of cardiac abnormalities following a sustained ischemic insult5 This same phenomenon has been shown in humans Applying an inflated blood pressure cuff to the upper or lower limb has shown efficacy for protection in people undergoing cardiac surgeries67 undergoing elective surgery to repair abdominal aortic aneurysm8 experiencing MI9 and with symptomatic intracranial arterial stenosis7
The mechanisms underlying the neuroplastic and neuroprotective effects of ischemic conditioning are not fully understood At this time the literature indicates that there are both humoral and neural mechanisms responsible for the protection and the plasticity It is clear that ischemic conditioning results in widespread physiological effects and that the observed effects work through multiple mechanistic pathways
The next translational step is to investigate whether combining ischemic conditioning with behavioral training has the ability to augment motor learning Specifically we will employ remote limb ischemic conditioning via inflationdeflation of a blood pressure cuff with the objective of activating the endogenous pathways shown to elicit neuroplasticity If eventually effective RLIC could have profound effect on the rehabilitation and recovery of motor function in people with stroke It is important to first start this translational investigation in neurologically intact people in order to determine optimal protocols for people with stroke
The purpose of this study is to test the effect of number of RLIC cycles on motor learning in neurologically intact adults and if we can find a physiological blood marker related to effective administration of RLIC We hypothesize that 3 cycles of RLIC will be sufficient to enhance motor leaning compared to sham conditioning and that there will be a dose-dependent number of cycles response in learning thus making training more efficient more effective and longer-lasting Determining the number of cycles necessary to elicit the benefits of RLIC is important in developing the most effective and least burdensome treatment for future patients with motor deficits
There is a growing body of literature which suggests that inducing a transient state of systemic ischemia has the potential to induce spinal plasticity strengthen spared pathways to motorneurons and lead to improved motor recovery following neurological injury12 Specifically daily systemic ischemic conditioning has been shown to improve both forelimb and respiratory motor function in rodent models of chronic cervical spinal injury13 Moreover systemic ischemic conditioning resulted in increased ankle strength single session2 and augmented walking speed and endurance 5 sessions4 in humans with motor incomplete spinal cord injuries
In a related area of research it has been shown that ischemic conditioning administered peripherally represents a strategy for harnessing the bodys endogenous protective capabilities against lethal levels of ischemia With this technique applying brief ischemia and reperfusion to a remote organ or tissue results in significantly reduced damage from subsequent exposures to ischemia For example applying a tourniquet and creating hypoxia in a rats hindlimb for 10 minutes reduced the extent of cardiac abnormalities following a sustained ischemic insult5 This same phenomenon has been shown in humans Applying an inflated blood pressure cuff to the upper or lower limb has shown efficacy for protection in people undergoing cardiac surgeries67 undergoing elective surgery to repair abdominal aortic aneurysm8 experiencing MI9 and with symptomatic intracranial arterial stenosis7
The mechanisms underlying the neuroplastic and neuroprotective effects of ischemic conditioning are not fully understood At this time the literature indicates that there are both humoral and neural mechanisms responsible for the protection and the plasticity It is clear that ischemic conditioning results in widespread physiological effects and that the observed effects work through multiple mechanistic pathways
The next translational step is to investigate whether combining ischemic conditioning with behavioral training has the ability to augment motor learning Specifically we will employ remote limb ischemic conditioning via inflationdeflation of a blood pressure cuff with the objective of activating the endogenous pathways shown to elicit neuroplasticity If eventually effective RLIC could have profound effect on the rehabilitation and recovery of motor function in people with stroke It is important to first start this translational investigation in neurologically intact people in order to determine optimal protocols for people with stroke
The purpose of this study is to test the effect of number of RLIC cycles on motor learning in neurologically intact adults and if we can find a physiological blood marker related to effective administration of RLIC We hypothesize that 3 cycles of RLIC will be sufficient to enhance motor leaning compared to sham conditioning and that there will be a dose-dependent number of cycles response in learning thus making training more efficient more effective and longer-lasting Determining the number of cycles necessary to elicit the benefits of RLIC is important in developing the most effective and least burdensome treatment for future patients with motor deficits
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD085930 | NIH | None | httpsreporternihgovquickSearchR01HD085930 |