Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05163639
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2021-11-23
Brief Title:
Spinal Cord Associative Plasticity Study
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Spinal Cord Associative Plasticity Study
Status:
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:
SCAP
Brief Summary:
Spinal cord associative plasticity SCAP is a combined cortical and spinal electrical stimulation technique developed to induce recovery of arm and hand function in spinal cord injury
The proposed study will advance understanding of SCAP which is critical to its effective translation to human therapy The purpose of the study is to
1 Determine whether signaling through the spinal cord to the muscles can be strengthened by electrical stimulation
2 Improve our understanding of the spinal cord and how it produces movement
3 Determine whether spinal surgery to relieve pressure on the spinal cord can improve its function
Aim 1 is designed to advance mechanistic understanding of spinal cord associative plasticity SCAP
Aim 2 will determine whether SCAP increases spinal cord excitability after the period of repetitive pairing In rats SCAP augments muscle activation for hours after just 5 minutes of paired stimuli
Whereas Aims 1 and 2 focused on the effects of paired stimulation in the context of uninjured spinal cord Aim 3 assesses whether paired stimulation can be effective across injured cord segments Aim 3 will incorporate the experiments from Aim 1 and 2 but in people with SCI either traumatic or pre-operative patients with myelopathy in non-invasive experiments or targeting myelopathic segments in intraoperative segments
The proposed study will advance understanding of SCAP which is critical to its effective translation to human therapy The purpose of the study is to
1 Determine whether signaling through the spinal cord to the muscles can be strengthened by electrical stimulation
2 Improve our understanding of the spinal cord and how it produces movement
3 Determine whether spinal surgery to relieve pressure on the spinal cord can improve its function
Aim 1 is designed to advance mechanistic understanding of spinal cord associative plasticity SCAP
Aim 2 will determine whether SCAP increases spinal cord excitability after the period of repetitive pairing In rats SCAP augments muscle activation for hours after just 5 minutes of paired stimuli
Whereas Aims 1 and 2 focused on the effects of paired stimulation in the context of uninjured spinal cord Aim 3 assesses whether paired stimulation can be effective across injured cord segments Aim 3 will incorporate the experiments from Aim 1 and 2 but in people with SCI either traumatic or pre-operative patients with myelopathy in non-invasive experiments or targeting myelopathic segments in intraoperative segments
Detailed Description:
For people with cervical spinal cord injury SCI regaining hand function is their highest priority Currently there are no effective treatments for people living with paralysis or profound weakness after SCI The goal of this project is to translate a promising therapy for improving arm and hand function after partial spinal cord injury to humans The approach promotes repair of residual brain to spinal cord connections using combined motor cortex and spinal cord stimulation
The direct brain to spinal cord connection is critical for skilled hand movement in health and for the loss of movement after injury After spinal cord injury many nerve connections for movement are preserved These connections can be strengthened by electrical stimulation
The investigator has previously demonstrated that pairing brain and spinal cord stimulation strengthens spinal connections in rats But it is unknown whether this is also applicable in humans This study is designed to test this in people undergoing spine surgery for pain or decreased movement as well as non-invasively in people with traumatic spinal cord injury There are three main goals of this project First the investigator will stimulate brain and spinal cord intra-operatively and non-invasively to try to study the influence of the timing of pairing brain and spinal cord stimulation Second the investigator will study how repeating the optimal timing spinal cord associative plasticity SCAP will influence muscle responses over a longer period of time when relatively uninjured parts of the spinal cord are targeted Finally the investigator will study how the influence of this protocol changes when injured parts of the cord are targeted Stimulation of brain and spinal cord intra-operatively will be performed with the same devices that maintain safety during the surgery while non-invasive stimulation will be performed with non-significant risk devices
Participants Uninjured volunteers individuals with chronic 1 year cervical SCI and individuals with cervical myelopathy or radiculopathy requiring clinically indicated decompressive surgery will be recruited SCI and myelopathy participants will have partially retained motor function in the hand scoring 1-4 out of 5 on manual muscle testing of finger extension finger flexion or finger abduction in left or right hand Participants will also require detectable F-wave responses of the left or right abductor pollicis brevis APB to median nerve stimulation andor first dorsal interosseous muscle FDI to ulnar nerve stimulation
The direct brain to spinal cord connection is critical for skilled hand movement in health and for the loss of movement after injury After spinal cord injury many nerve connections for movement are preserved These connections can be strengthened by electrical stimulation
The investigator has previously demonstrated that pairing brain and spinal cord stimulation strengthens spinal connections in rats But it is unknown whether this is also applicable in humans This study is designed to test this in people undergoing spine surgery for pain or decreased movement as well as non-invasively in people with traumatic spinal cord injury There are three main goals of this project First the investigator will stimulate brain and spinal cord intra-operatively and non-invasively to try to study the influence of the timing of pairing brain and spinal cord stimulation Second the investigator will study how repeating the optimal timing spinal cord associative plasticity SCAP will influence muscle responses over a longer period of time when relatively uninjured parts of the spinal cord are targeted Finally the investigator will study how the influence of this protocol changes when injured parts of the cord are targeted Stimulation of brain and spinal cord intra-operatively will be performed with the same devices that maintain safety during the surgery while non-invasive stimulation will be performed with non-significant risk devices
Participants Uninjured volunteers individuals with chronic 1 year cervical SCI and individuals with cervical myelopathy or radiculopathy requiring clinically indicated decompressive surgery will be recruited SCI and myelopathy participants will have partially retained motor function in the hand scoring 1-4 out of 5 on manual muscle testing of finger extension finger flexion or finger abduction in left or right hand Participants will also require detectable F-wave responses of the left or right abductor pollicis brevis APB to median nerve stimulation andor first dorsal interosseous muscle FDI to ulnar nerve stimulation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01NS124224-01 | NIH | None | httpsreporternihgovquickSearch1R01NS124224-01 |