Spinal Cord Stimulation for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Disqualifiers: Stimulation devices, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The proposed study seeks to understand how the cervical spinal cord should be stimulated after injury through short-term physiology experiments that will inform a preclinical efficacy trial. The purpose of this study is to determine which cervical levels epidural electrical stimulation (EES) should target to recruit arm and hand muscles effectively and selectively in spinal cord injury (SCI).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have stimulation devices in the neck or chest, you may not be eligible to participate.
What data supports the effectiveness of the treatment Intraoperative stimulation of the cervical spinal cord for spinal cord injury?
Spinal cord stimulation (SCS) has shown promise in restoring function after spinal cord injuries, as it is driven by advances in understanding spinal cord lesions and compensatory mechanisms. Although primarily used for pain management, new strategies like spatiotemporal neuromodulation, combined with intensive rehabilitation, are being explored for their potential to improve outcomes in spinal cord injury patients.12345
Is spinal cord stimulation generally safe for humans?
How is intraoperative stimulation of the cervical spinal cord different from other treatments for spinal cord injury?
Intraoperative stimulation of the cervical spinal cord is unique because it involves direct electrical stimulation during surgery, which may allow for precise targeting and immediate feedback on its effects, unlike other treatments that are typically administered post-surgery or through less direct methods.45101112
Eligibility Criteria
This trial is for individuals who need cervical spine surgery due to conditions like a broken neck, spinal cord injury, or quadriplegia. It's not open to those with stimulation devices in the neck or chest, such as vagal nerve stimulators or pacemakers.Inclusion Criteria
I need surgery for my neck spine.
Exclusion Criteria
Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intraoperative Testing
Motor evoked responses to epidural electrical stimulation (EES) will be tested at cervical segments with and without myelopathy
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after intraoperative testing
4 weeks
Treatment Details
Interventions
- Intraoperative stimulation of the cervical spinal cord (Procedure)
Trial OverviewThe study is testing how stimulating the cervical spinal cord during surgery can help arm and hand muscle function after a spinal injury. Researchers want to find out which parts of the cervical spine should be targeted for optimal recovery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Arm 1 - Intraoperative ParticipantsExperimental Treatment1 Intervention
Motor evoked responses responses (MEPs) to epidural electrical stimulation (EES) will be tested at cervical segments with and without myelopathy in participants with cervical myelopathy.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Irving Medical CenterNew York, NY
The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/AllenNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
References
Explantation Rates of High Frequency Spinal Cord Stimulation in Two Outpatient Clinics. [2022]To report the explantation rates of high frequency 10 kHz spinal cord stimulation (SCS) in a real-world setting.
Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]OBJECTIVE Cervical spinal cord stimulation (cSCS) is used to treat pain of the cervical region and upper extremities. Case reports and small series have shown a relatively low risk of complication after cSCS, with only a single reported case of perioperative spinal cord injury in the literature. Catastrophic cSCS-associated spinal cord injury remains a concern as a result of underreporting. To aid in preoperative counseling, it is necessary to establish a minimum rate of spinal cord injury and surgical complication following cSCS. METHODS The Nationwide Inpatient Sample (NIS) is a stratified sample of 20% of all patient discharges from nonfederal hospitals in the United States. The authors identified discharges with a primary procedure code for spinal cord stimulation (ICD-9 03.93) associated with a primary diagnosis of cervical pathology from 2002 to 2011. They then analyzed short-term safety outcomes including the presence of spinal cord injury and neurological, medical, and general perioperative complications and compared outcomes using univariate analysis. RESULTS Between 2002 and 2011, there were 2053 discharges for cSCS. The spinal cord injury rate was 0.5%. The rates of any neurological, medical, and general perioperative complications were 1.1%, 1.4%, and 11.7%, respectively. There were no deaths. CONCLUSIONS In the largest series of cSCS, the risk of spinal cord injury was higher than previously reported (0.5%). Nonetheless, this procedure remains relatively safe, and physicians may use these data to corroborate the safety of cSCS in an appropriately selected patient population. This may become a key treatment option in an increasingly opioid-dependent, aging population.
Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]Spinal cord stimulation (SCS) is an approved treatment for intractable pain and has recently emerged as a promising area of research for restoring function after spinal cord lesion. This review will focus on the historical evolution of this transition and the path that remains to be taken for these methods to be rigorously evaluated for application in clinical practice. New developments in SCS are being driven by advances in the understanding of spinal cord lesions at the molecular, cellular, and neuronal levels, as well as the understanding of compensatory mechanisms. Advances in neuroengineering and the computational neurosciences have enabled the development of new conceptual SCS strategies, such as spatiotemporal neuromodulation, which allows spatially selective stimulation at precise time points during anticipated movement. It has also become increasingly clear that these methods are only effective when combined with intensive rehabilitation techniques, such as new task-oriented methods and robotic aids. The emergence of innovative approaches to spinal cord neuromodulation has sparked significant enthusiasm among patients and in the media. Non-invasive methods are perceived to offer improved safety, patient acceptance, and cost-effectiveness. There is an immediate need for well-designed clinical trials involving consumer or advocacy groups to evaluate and compare the effectiveness of various treatment modalities, assess safety considerations, and establish outcome priorities.
Electrophysiologic monitoring for placement of laminectomy leads for spinal cord stimulation under general anesthesia. [2022]Spinal cord stimulation (SCS) is a valid option for intractable neuropathic pain syndromes, yet some patients cannot undergo the standard awake procedure. Our retrospective study chronicles laminectomy-electrode placement for SCS under general anesthesia and use of compound muscle action potentials (CMAPs) to guide placement in the absence of patient verbal feedback.
Implantation of Surgical Paddle Electrodes Using Percutaneous Biportal-Endoscopic Technique for Spinal Cord Stimulation: An Anatomical Feasibility Study in Human Cadavers. [2023]Spinal cord stimulation is a technique in which different types of electrodes are placed in the spinal epidural space for neuromodulation. Surgical paddle electrodes (SEs) are usually implanted by a surgeon by performing open surgery with laminectomy. Recent advances in endoscopic spine surgery provide another option for minimally invasive SE implantation.
Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial. [2023]This study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial.
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]Spinal cord stimulation (SCS) is a safe, reversible surgical treatment for complex regional pain syndrome and failed back surgery syndrome refractory to conventional medical management. Paddle electrodes are routinely used for the permanent implant because of the reduced risk of migration, lower energy requirements, and expanded coverage options. The risks associated with paddle lead removal are not well defined in the literature.
Effects of epidural electrical stimulation modalities on spinal cord function and morphology in cats. [2013]The safety of direct electrical stimulation to the spinal cord as used in spinal cord monitoring is controversial. This investigation was undertaken to determine the critical condition of continuous electrical stimulation over a period of 30 min with varying intensities and pulse durations, and the level of safety of intermittent stimulation of 100 pulses with 10 mA current of 0.3 msec duration with varying resting intervals. The spinal cord was evaluated by spinal cord evoked potentials (SCEP) recording and histological examination. The intensity of continuous stimulation greater than 10 mA of 0.3 msec duration resulted in permanent changes in SCEP, focal colliquative necrosis of the cord, and acceleration of the permeability of the intrinsic vessels. In the intermittent stimulation with 1-min resting intervals, spinal cord lesions were not observed.
Cortical evoked potentials used for placement of a laminotomy lead array: a case report. [2022]We describe a technique for placement of a cervical spinal cord electrode under general anesthesia using the contacts as cortical evoked potential stimulating electrodes.
[Spinal cord stimulation and failed back surgery syndrome. Clinical results with laminectomy electrodes]. [2015]Spinal cord stimulation is a widely-accepted technique in the treatment of back pain resulting from failed back surgery. Classically, stimulation has been carried out with percutaneous electrodes implanted under local anaesthesia and sedation. However, the ease of migration and the difficulty of reproducing electrical paresthesias in large areas with such electrodes has led to increasing use of surgical plate leads, which have the disadvantage of the need for general anaesthesia and a laminectomy for implantation.
Spinal cord stimulation for chronic pain. [2018]Spinal cord stimulation (SCS) is a form of therapy used to treat certain types of chronic pain. It involves an electrical generator that delivers pulses to a targeted spinal cord area. The leads can be implanted by laminectomy or percutaneously and the source of power is supplied by an implanted battery or by an external radio-frequency transmitter. The exact mechanism of action of SCS is poorly understood.
Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes. [2019]The clinical use of spinal cord stimulation for treatment of chronic intractable pain has been increasingly successful because of recent technical improvements, particularly the development of multiple-contact electrodes supported by programmable implanted pulse generators. Contemporary electrodes can be placed percutaneously in some cases and require a limited laminectomy in other cases.