Ignite Creation Date:
2024-05-06 @ 12:17 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01538693
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2012-01-24
Brief Title:
Molecular Markers of Neuroplasticity During Exercise in People With Incomplete Spinal Cord Injury
Sponsor:
T George Hornby
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Molecular Markers of Neuroplasticity During High-Intensity Exercise in Subjects With Incomplete Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2015-05
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 purpose of this study is to determine whether exercising walking at different intensities increases levels of factors in the blood and saliva that are known to impact neuroplasticity how the connections in the spinal cord and brain can change and if these levels are changed by pairing exercise with a single dose of commonly used prescription drugs or by your mood
Detailed Description:
The protein brain-derived neurotrophic factor BDNF is known to promote cell survival improve synaptic function and induce neuronal morphological changes Consequently BDNF plays a major role in neuroplasticity and the ability of the central nervous system to adapt and recover following injury Regardless of the molecular mechanisms by which this occurs which are poorly understood potentiating the expression of BDNF following spinal cord injury has been shown to improve functional outcomes in animals1 2 It is well documented in both animal and human literature that the production BDNF increases with physical exercise in healthy populations and individuals with chronic disease or disability 3 The literature suggests that this increase is proportional to the intensity of exercise though the parameters of exercise to maximize this effect are poorly understood 2 4-6 From animal research it has been postulated that serotonin 5HT plays a role in the mechanism of increase in BDNF expression 7-9 with findings that specifically demonstrate potentiation of the exercise-induced expression with antidepressant treatment10and a blunted response when monoaminergic signaling is blocked11 A specific genetic variation in the BDNF gene found in approximately 30 of the population has also been noted as an important factor in the proper release of BDNF with associated deficits in motor learning 12 13 Initial evidence also suggests that this polymorphism may have an impact of the relationship between exercise and BDNF 14 15 The objective of this study is the evaluate the response of serum concentrations of brain-derived neurotrophic factor BDNFs to an acute bout of exercise in ambulatory people with incomplete spinal cord injury additionally to examine the effect of pharmacological agents that alter serotonergic 5HT transmission on this exercise-induced change in BDNFs To achieve this objective we will investigate BDNFs during a treadmill test alone and in combination with two commonly used medications escitalopram oxalate a selective-5HT reuptake inhibitor SSRI and cyproheptadine CYPRO a 5HT antagonist
Studies have also shown a relationship of BDNF to mood in particular depression A secondary study will be performed in parallel with the primary study with the purpose of examining mood and how it correlates with the molecular markers for neuroplasticity as individuals participate in the repeated exercise and the other stated interventions As the subjects progress over the course of the study time mood may change and may impact the relationship of the BDNF to the primary interventions
Studies have also shown a relationship of BDNF to mood in particular depression A secondary study will be performed in parallel with the primary study with the purpose of examining mood and how it correlates with the molecular markers for neuroplasticity as individuals participate in the repeated exercise and the other stated interventions As the subjects progress over the course of the study time mood may change and may impact the relationship of the BDNF to the primary interventions
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