Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438991
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-21
Brief Title:
Spinal Cord Stimulation for Lower Extremity Function
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Epidural Spinal Cord Stimulation for Lower Extremity Motor Function in Spinal Cord Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
This prospective clinical study will investigate the ability of different spine imaging characteristics to predict ambulation recovery responsiveness using epidural spinal cord stimulator SCS in patients with chronic incomplete spinal cord injury SCI
Epidural spinal cord stimulation below the level of injury can restore previously lost lower extremity voluntary motor function for some patients The goal of this study is to establish whether spine imaging can be utilized as a biomarker to predict which patients will respond to spinal cord stimulation
Epidural spinal cord stimulation below the level of injury can restore previously lost lower extremity voluntary motor function for some patients The goal of this study is to establish whether spine imaging can be utilized as a biomarker to predict which patients will respond to spinal cord stimulation
Detailed Description:
Ten patients with chronic spinal cord injury who are scheduled to receive a spinal cord stimulator for refractory chronic pain will be recruited throughout the Mass General Brigham health system At baseline participants will undergo a neurologic strength exam Magnetic Resonance Imaging MRI of the spine and brain electromyography EMG of the lower extremities and will complete a battery of pain motor function and quality of life questionnaires
Phase 1 The SCS Optimization phase consists of weekly research visits during the first month post-SCS implant Settings of the spinal cord stimulator parameters will be modified for activation and optimal voluntary control of lower extremity muscles
Phase 2 The Individualized Neurorehabilitation phase consists of 4 weekly visits for a 5-month period Participants will undergo neurorehabilitation with the stimulation settings turned on for motor control Neurorehabilitation will be individualized and will progressively increase participants physical activity including assistedindependent standing stepping and ambulation within safe limits Participants will undergo monthly muscle strength and surface EMG testing
At the end of each research visit or neurorehabilitation session SCS settings will be adjusted to the original pain management parameters
At the 6-month follow up participants will undergo a neurologic strength exam MRI of the spine and brain EMG of the lower extremities and a battery of questionnaires After the last follow up visit participants will have the opportunity to continue a long-term follow up or exit the study SCS parameters will be adjusted to the pain management settings
Phase 1 The SCS Optimization phase consists of weekly research visits during the first month post-SCS implant Settings of the spinal cord stimulator parameters will be modified for activation and optimal voluntary control of lower extremity muscles
Phase 2 The Individualized Neurorehabilitation phase consists of 4 weekly visits for a 5-month period Participants will undergo neurorehabilitation with the stimulation settings turned on for motor control Neurorehabilitation will be individualized and will progressively increase participants physical activity including assistedindependent standing stepping and ambulation within safe limits Participants will undergo monthly muscle strength and surface EMG testing
At the end of each research visit or neurorehabilitation session SCS settings will be adjusted to the original pain management parameters
At the 6-month follow up participants will undergo a neurologic strength exam MRI of the spine and brain EMG of the lower extremities and a battery of questionnaires After the last follow up visit participants will have the opportunity to continue a long-term follow up or exit the study SCS parameters will be adjusted to the pain management settings
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