Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541041
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Electrical Stimulation During Nerve Transfer Surgery for Cervical Spinal Cord Injury
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 goal of this prospective observational study is to determine whether brief intraoperative electrical stimulation and temporary postoperative electrical stimulation improve motor andor pain outcomes for patients with cervical spinal cord injury undergoing standard of care nerve transfer surgery to improve hand function
The main hypotheses include
Hypothesis 1 Brief intraoperative electrical stimulation of the donor nerves will result in improved motor outcomes hand function compared to standard nerve transfer surgery in patients with cervical spinal cord injuries
Hypothesis 2 Placement of a temporary peripheral nerve stimulator for 60 days of postoperative electrical stimulation will result in improved pain outcomes compared to standard nerve transfer surgery in patients with cervical spinal cord injuries
Researchers will prospectively enroll patients with cervical spinal cord injury and no hand function who will undergo standard of care nerve transfer surgery combined with standard of care brief intraoperative electrical stimulation and temporary postoperative electrical stimulation Motor and pain outcomes will be compared to a retrospective group of patients who underwent nerve transfer surgery without intraoperative or postoperative electrical stimulation
Participants will receive standard medical care nothing experimental as part of this study Participants will
Have a preoperative assessment including physical examination electrodiagnostic studies functional electrical stimulation and will complete questionnaires assessing function and quality of life
Agree upon a surgical plan including the specific nerve transfers to be performed and whether to include brief intraoperative electrical stimulation andor temporary postoperative electrical stimulation before being considered for enrollment in the study
Will undergo standard of care nerve transfer surgery with at least one nerve transfer targeting improvement in hand function and will receive brief intraoperative electrical stimulation of the donor nerves and placement of a temporary peripheral nerve stimulator
Will follow-up with the surgeon 3 6 12 24 and 36 months after the surgery
Will have a physical examination and will complete questionnaires at the postoperative visits
Will participate in hand therapy following the operation
Will be eligible for placement of a permanent peripheral nerve stimulator depending on response to the temporary peripheral nerve stimulator
The main hypotheses include
Hypothesis 1 Brief intraoperative electrical stimulation of the donor nerves will result in improved motor outcomes hand function compared to standard nerve transfer surgery in patients with cervical spinal cord injuries
Hypothesis 2 Placement of a temporary peripheral nerve stimulator for 60 days of postoperative electrical stimulation will result in improved pain outcomes compared to standard nerve transfer surgery in patients with cervical spinal cord injuries
Researchers will prospectively enroll patients with cervical spinal cord injury and no hand function who will undergo standard of care nerve transfer surgery combined with standard of care brief intraoperative electrical stimulation and temporary postoperative electrical stimulation Motor and pain outcomes will be compared to a retrospective group of patients who underwent nerve transfer surgery without intraoperative or postoperative electrical stimulation
Participants will receive standard medical care nothing experimental as part of this study Participants will
Have a preoperative assessment including physical examination electrodiagnostic studies functional electrical stimulation and will complete questionnaires assessing function and quality of life
Agree upon a surgical plan including the specific nerve transfers to be performed and whether to include brief intraoperative electrical stimulation andor temporary postoperative electrical stimulation before being considered for enrollment in the study
Will undergo standard of care nerve transfer surgery with at least one nerve transfer targeting improvement in hand function and will receive brief intraoperative electrical stimulation of the donor nerves and placement of a temporary peripheral nerve stimulator
Will follow-up with the surgeon 3 6 12 24 and 36 months after the surgery
Will have a physical examination and will complete questionnaires at the postoperative visits
Will participate in hand therapy following the operation
Will be eligible for placement of a permanent peripheral nerve stimulator depending on response to the temporary peripheral nerve stimulator
Detailed Description:
Background
Spinal cord injury SCI is a major problem facing the general public with particular relevance for military personnel given the high frequency of SCI in combat-related injuries Nerve transfer surgery is one option for restoring function in cervical SCI patients that shows great promise A nerve transfer involves sacrificing a working nerve that arises from a spinal cord segment above the zone of injury and connecting it to a non-working nerve to reinnervate a target muscle Restoring hand function is consistently rated by SCI patients including our lived experience consultants as most important even more important than walking or bowelbladder control Nerve transfer surgery has been shown to be effective in restoring hand function but additional improvements are needed especially for restoring grasp Furthermore pain is a significant problem in patients with cervical SCI with an unmet need for options for treating pain in these patients Peripheral nerve electrical stimulation has been shown to improve axonal regeneration muscle reinnervation and motor recovery and has been used to treat neuropathic pain Thus the use of peripheral nerve electrical stimulation has the potential to simultaneously improve motor and pain outcomes in cervical SCI patients undergoing nerve transfer surgery but has never been studied
ObjectivesHypotheses
The investigators hypothesize that brief intraoperative electrical stimulation of the donor nerves will result in improved motor outcomes compared to standard nerve transfer We also hypothesize that placement of a temporary peripheral nerve stimulator for 60 days of postoperative electrical stimulation will result in improved pain outcomes compared to standard nerve transfer
Specific Aim
Compare motor and pain outcomes for nerve transfers in cervical spinal cord injury patients with and without peripheral nerve stimulation
Study Design
A single center unblinded single arm non-randomized observational design will be utilized A total of 10 patients with cervical spinal cord injury classified as ASIA A or B with International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7 will be recruited and will undergo standard end-to-end nerve transfer surgery targeting restoration of finger extension posterior interosseous nerve recipient and finger flexion anterior interosseous nerve recipient according to standard clinical care The test intervention will consist of intraoperative brief electrical stimulation of the donor nerves and postoperative electrical stimulation via a temporary implantable peripheral nerve stimulator Intraoperative brief electrical stimulation BES will be performed using a handheld nerve stimulator to stimulate the donor nerves at 2 mA with a 200 µs pulse duration for 10 minutes The implantable peripheral nerve stimulator will be programmed to optimize postoperative pain control on an individualized basis The peripheral nerve stimulator will be explanted after 60 days as is intended for this device The primary outcomes will be manual motor testing graded on the Medical Research Council MRC scale 0-5 for the extensor digitorum communis EDC and flexor pollicis longus FPL and the Numeric Rating Scale NRS for pain in the treated extremity 0-10 Patients will have a baseline preoperative electrodiagnostic study and functional electrical stimulation performed with the decision for surgery occurring as part of standard clinical care Assessments will occur preoperatively and postoperatively at 3 6 12 24 and 36 months The researchers will compare these data to a retrospective group of patients who underwent similar nerve transfer surgery without intraoperative or postoperative electrical stimulation
Spinal cord injury SCI is a major problem facing the general public with particular relevance for military personnel given the high frequency of SCI in combat-related injuries Nerve transfer surgery is one option for restoring function in cervical SCI patients that shows great promise A nerve transfer involves sacrificing a working nerve that arises from a spinal cord segment above the zone of injury and connecting it to a non-working nerve to reinnervate a target muscle Restoring hand function is consistently rated by SCI patients including our lived experience consultants as most important even more important than walking or bowelbladder control Nerve transfer surgery has been shown to be effective in restoring hand function but additional improvements are needed especially for restoring grasp Furthermore pain is a significant problem in patients with cervical SCI with an unmet need for options for treating pain in these patients Peripheral nerve electrical stimulation has been shown to improve axonal regeneration muscle reinnervation and motor recovery and has been used to treat neuropathic pain Thus the use of peripheral nerve electrical stimulation has the potential to simultaneously improve motor and pain outcomes in cervical SCI patients undergoing nerve transfer surgery but has never been studied
ObjectivesHypotheses
The investigators hypothesize that brief intraoperative electrical stimulation of the donor nerves will result in improved motor outcomes compared to standard nerve transfer We also hypothesize that placement of a temporary peripheral nerve stimulator for 60 days of postoperative electrical stimulation will result in improved pain outcomes compared to standard nerve transfer
Specific Aim
Compare motor and pain outcomes for nerve transfers in cervical spinal cord injury patients with and without peripheral nerve stimulation
Study Design
A single center unblinded single arm non-randomized observational design will be utilized A total of 10 patients with cervical spinal cord injury classified as ASIA A or B with International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7 will be recruited and will undergo standard end-to-end nerve transfer surgery targeting restoration of finger extension posterior interosseous nerve recipient and finger flexion anterior interosseous nerve recipient according to standard clinical care The test intervention will consist of intraoperative brief electrical stimulation of the donor nerves and postoperative electrical stimulation via a temporary implantable peripheral nerve stimulator Intraoperative brief electrical stimulation BES will be performed using a handheld nerve stimulator to stimulate the donor nerves at 2 mA with a 200 µs pulse duration for 10 minutes The implantable peripheral nerve stimulator will be programmed to optimize postoperative pain control on an individualized basis The peripheral nerve stimulator will be explanted after 60 days as is intended for this device The primary outcomes will be manual motor testing graded on the Medical Research Council MRC scale 0-5 for the extensor digitorum communis EDC and flexor pollicis longus FPL and the Numeric Rating Scale NRS for pain in the treated extremity 0-10 Patients will have a baseline preoperative electrodiagnostic study and functional electrical stimulation performed with the decision for surgery occurring as part of standard clinical care Assessments will occur preoperatively and postoperatively at 3 6 12 24 and 36 months The researchers will compare these data to a retrospective group of patients who underwent similar nerve transfer surgery without intraoperative or postoperative electrical stimulation
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