Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564714
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-01-30
Brief Title:
Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury to Promote Long-term Neurofunctional Recovery a Randomized Clinical Trial
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:
The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunctional recovery after tSCI
The main questions it aims to answer are
1 Assess the safety of early baclofen treatment during acute care after SCI
2 Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI in terms of mobility global functional independence neurological recovery pain and spasticity
The early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake up to a maximum 80 mg total per day until achieving an optimal response ie when spasticity is no longer problematic The control group however will receive the usual routine care at our institution as per which baclofen is initiated by the attending physician ie physiatrist or spine surgeon only when acute spasticity becomes severe and problematic
The main questions it aims to answer are
1 Assess the safety of early baclofen treatment during acute care after SCI
2 Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI in terms of mobility global functional independence neurological recovery pain and spasticity
The early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake up to a maximum 80 mg total per day until achieving an optimal response ie when spasticity is no longer problematic The control group however will receive the usual routine care at our institution as per which baclofen is initiated by the attending physician ie physiatrist or spine surgeon only when acute spasticity becomes severe and problematic
Detailed Description:
Spasticity is a condition in which muscles are abnormally stiff or tight and interfere with normal movement Following spinal cord injury SCI spasticity is common affecting up to 70 of patients in the chronic stage 6 months or more after the injury 1-4 After SCI spasticity is due to a stretch reflex disorder of sensorimotor control following an upper motor neuron lesion ie a lesion involving the neurons carrying the information within the spinal cord Clinically spasticity manifests as a complex syndrome of velocity-dependent hypertonia clonus rhythmic oscillating stretch reflex and spasms involuntary muscle contractions that can have profound consequences on function and quality of life
Traditionally the clinical impact of spasticity has been mostly recognized during the subacute and chronic phases after SCI Based upon the current management paradigm the great majority of individuals with spasticity will receive pharmaceutical treatment for spasticity only during the rehabilitation period weeks or months after the injury when the clinical manifestations become severe and problematic The investigators have challenged this long-held belief by proposing their paradigm shift towards early recognition and treatment of spasticity during the acute within the first month after SCI after showing that about half of individuals will develop clinical signs of early spasticity during the acute hospitalization and that acute spasticity is associated with poor long-term outcomes
In particular the investigators found that long-term mobility is significantly decreased in individuals presenting acute spasticity within the first month after the SCI Our preliminary data suggest that prompt pharmacological treatment with baclofen - an anti-spasmodic medication - during the acute hospitalization improves neurological recovery in the presence of acute spasticity Based on these preliminary findings the overarching hypothesis of this study is that long-term neurofunctional outcomes are improved by early detection of acute spasticity and immediate treatment with oral baclofen
Our team of experienced clinician-scientists specialized in SCI care therefore propose a single-site pilot randomized clinical trial including 55 patients admitted for a traumatic SCI tSCI in order to evaluate the safety and neurofunctional benefits of early baclofen treatment ie as soon as any signs of spasticity are observed within the first month after the injury during the acute hospitalization
Traditionally the clinical impact of spasticity has been mostly recognized during the subacute and chronic phases after SCI Based upon the current management paradigm the great majority of individuals with spasticity will receive pharmaceutical treatment for spasticity only during the rehabilitation period weeks or months after the injury when the clinical manifestations become severe and problematic The investigators have challenged this long-held belief by proposing their paradigm shift towards early recognition and treatment of spasticity during the acute within the first month after SCI after showing that about half of individuals will develop clinical signs of early spasticity during the acute hospitalization and that acute spasticity is associated with poor long-term outcomes
In particular the investigators found that long-term mobility is significantly decreased in individuals presenting acute spasticity within the first month after the SCI Our preliminary data suggest that prompt pharmacological treatment with baclofen - an anti-spasmodic medication - during the acute hospitalization improves neurological recovery in the presence of acute spasticity Based on these preliminary findings the overarching hypothesis of this study is that long-term neurofunctional outcomes are improved by early detection of acute spasticity and immediate treatment with oral baclofen
Our team of experienced clinician-scientists specialized in SCI care therefore propose a single-site pilot randomized clinical trial including 55 patients admitted for a traumatic SCI tSCI in order to evaluate the safety and neurofunctional benefits of early baclofen treatment ie as soon as any signs of spasticity are observed within the first month after the injury during the acute hospitalization
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