Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06030531
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-09-11
First Post:
2022-04-07
Brief Title:
Spasticity and Functional Recovery After SCI
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Spasticity and Functional Recovery in Humans With Acute to Subacute Spinal Cord Injury
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-09
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:
Spasticity is one of the most common symptoms manifested in humans with spinal cord injury SCI However the neural mechanisms underlying the development of spasticity over time after an acute SCI are not yet understood Using electrophysiological and imaging techniques along with traditional measurements of neurological recovery in the acute rehabilitation setting including physical exam and functional assessments the investigators aim to examine the relationship between development of spasticity residual descending motor pathways and functional and neurological recovery in humans with SCI from acute to subacute phase
Detailed Description:
The purpose of this study is to measure changes to motor-evoked potentials MEPs and to evaluate if the development of spasticity is related to residual descending motor pathways and to a better neurological recovery and functional improvement in individuals with SCI from the acute to the subacute phase The investigators will also test for the presence of biological markers in the blood that may correlate with levels of spasticity or neurological recovery and functional improvement including the presence or absence of neuroplastic genetic polymorphisms eg BDNF Val66Met polymorphism as well as circulating levels of neuroplastic eg BDNF or inflammatory factors eg interleukins TNF that may affect neuronal growth and functional restoration
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