Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384170
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-22
Brief Title:
Closed Loop Spinal Cord Stimulation for Neuromodulation of Upper Motor Neuron Lesion Spasticity
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Closed Loop Spinal Cord Stimulation SCS for Neuromodulation of UMN-Lesion Spasticity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
CLONUS
Brief Summary:
Spasticity is characterized by increased muscle tension and is a classic consequence of upper motor neuron UMN damage in the central nervous system such as from stroke or trauma Clinically it presents as muscle resistance to passive stretching along with clasp-knife rigidity clonus increased tendon reflexes and muscle spasms An imbalance of the descending inhibitory and muscle stretch reflexes is thought to be the cause of spasticity Post-stroke spasticity is a common condition that occurs in 375-45 of cases in the acute stage and 19-574 in the subacute stage after a stroke At 6 months post-stroke spasticity develops in 426-495 of cases and at one year it affects 35-574 of individuals In patients with cerebral palsy CP incidence is almost 80 while in those living with spinal cord injury the number approaches up to 93 Traumatic brain injury TBI patients have a higher prevalence on initial admission to neurorehabilitation but one in three patients will have chronic spasticity However the Defense and Veterans Brain Injury Center report a rate of TBIs amongst deployed veterans to be around 11-23 mostly from blast and explosive trauma
There have been studies as early as the 1980s exploring the efficacy of SCS for spasticity control however the credibility of many of these studies is constrained due to an incomplete comprehension of spasticitys underlying mechanisms outdated research methods and early limitations in implantable device technology Intrathecal pumps for baclofen have remained as the mainstay for refractory spasticity however it comes with associated risks such as chemical dependence leading to acute baclofen withdrawal and requiring frequent refill requirement Most importantly it does not yield functional improvement of muscle activity just suppression of spasticity Botox is also routinely used but due to heterogeneity in muscle involvement as well as variability in provider skill results may be inconsistent and short-lasting requiring frequent clinic visits for repeat injections to the affected muscle groups SCS may be able to address that gap in spasticity management
There have been studies as early as the 1980s exploring the efficacy of SCS for spasticity control however the credibility of many of these studies is constrained due to an incomplete comprehension of spasticitys underlying mechanisms outdated research methods and early limitations in implantable device technology Intrathecal pumps for baclofen have remained as the mainstay for refractory spasticity however it comes with associated risks such as chemical dependence leading to acute baclofen withdrawal and requiring frequent refill requirement Most importantly it does not yield functional improvement of muscle activity just suppression of spasticity Botox is also routinely used but due to heterogeneity in muscle involvement as well as variability in provider skill results may be inconsistent and short-lasting requiring frequent clinic visits for repeat injections to the affected muscle groups SCS may be able to address that gap in spasticity management
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None