Epidural Spinal Cord Stimulation for Spinal Cord Injury
(E-STAND Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
Must not be taking: Opioids, Antiplatelets, Anticoagulants, others
Disqualifiers: Cardiopulmonary issues, Dysautonomia, Mental illness, others
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take antiplatelet or anticoagulation agents around the time of surgery, and you cannot have a current or anticipated need for opioid pain medications.
What data supports the effectiveness of the treatment Epidural Spinal Cord Stimulation for Spinal Cord Injury?
Research shows that epidural spinal cord stimulation can effectively manage chronic pain in various conditions, such as reflex sympathetic dystrophy and failed back surgery syndrome, with many patients experiencing significant pain relief. Although the studies focus on pain management, the positive outcomes suggest potential benefits for spinal cord injury treatment, especially in carefully selected patients.
12345Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation is generally considered safe, with rare reports of serious complications like spinal cord injury. The most common issue is equipment failure, and while some risks like infection or dural puncture (a tear in the outer membrane of the spinal cord) exist, they are not common.
678910How is epidural spinal cord stimulation different from other treatments for spinal cord injury?
Epidural spinal cord stimulation (SCS) is unique because it uses electrical impulses to stimulate the spinal cord, which can help restore some motor and sensory functions after a spinal cord injury. Unlike other treatments that may focus solely on pain relief, SCS has shown potential in improving movement and autonomic functions, such as blood pressure regulation, when combined with rehabilitation exercises.
35111213Eligibility Criteria
This trial is for adults over 22 with stable, motor-complete paraplegia due to spinal cord injury between C6 and T10. Participants must have had the injury for over a year, be medically stable, able to consent, and commit to all appointments. Excluded are those with certain health risks or conditions that complicate surgery or rehabilitation.Inclusion Criteria
Willing to attend all scheduled appointments
My reflexes below my injury site work.
I have stable paralysis affecting my lower limbs.
+6 more
Exclusion Criteria
I need opioids for pain or have pain that might stop me from fully joining in the rehab program.
Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator
I have a spinal fracture that has not yet healed.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive epidural spinal cord stimulation to optimize parameter settings for volitional movement and autonomic function
12 months
Monthly visits for assessment and optimization
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Participant Groups
The study tests optimizing epidural spinal cord stimulation settings to restore voluntary leg movement in people with paraplegia. It also looks at improvements in autonomic functions like blood pressure control related to spinal cord injuries.
1Treatment groups
Experimental Treatment
Group I: Epidural Spinal Cord StimulationExperimental Treatment1 Intervention
Epidural Spinal Cord Stimulation
Epidural Spinal Cord Stimulation is already approved in European Union, United States, Canada for the following indications:
πͺπΊ Approved in European Union as Spinal Cord Stimulation for:
- Failed back surgery syndrome
- Complex regional pain syndrome
- Chronic neuropathic pain
- Ischemic pain
πΊπΈ Approved in United States as Spinal Cord Stimulation for:
- Failed back surgery syndrome
- Complex regional pain syndrome
- Chronic neuropathic pain
- Ischemic pain
- Diabetic neuropathy
π¨π¦ Approved in Canada as Spinal Cord Stimulation for:
- Failed back surgery syndrome
- Complex regional pain syndrome
- Chronic neuropathic pain
- Ischemic pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hennepin County Medical CenterMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
Minnesota Office of Higher EducationCollaborator
Minneapolis Veterans Affairs Medical CenterCollaborator
Hennepin County Medical Center, MinneapolisCollaborator
Hennepin Healthcare Research InstituteCollaborator
References
Epidural spinal cord stimulation in the management of reflex sympathetic dystrophy. [2018]Eighteen subjects with intractable pain due to reflex sympathetic dystrophy (RSD) underwent treatment by epidural spinal cord stimulation (SCS). All the patients had previously undergone multiple sympathetic blocks and/or surgical sympathectomy with either no results or only temporary therapeutic effects. Four subjects did not experience any beneficial effects during a 1-week trial and the electrode was removed, and 14 patients had the system internalized surgically. In 4 cases two separate systems (electrode + pulse generator) were implanted, in order to cover distant areas of the body involved by the disease (neck, shoulders, upper extremities, trunk and lower extremities). Follow-up varies from 4 to 14 months. In the implanted group, pain relief was absent in 3 patients, minimal in 1, moderate in 5 and good in 6. Pain relief was strictly limited to the body parts covered by the parasthesiae induced by SCS. In 3 patients, SCS produced visible changes in the swelling of the painful extremities. None of the patients was made neurologically worse. In 7 patients there were technical problems related to electrode breakage or migration, change in the pattern of paresthesiae and poor connection due to body fluid infiltration. All the problems were corrected surgically under local anesthesia. SCS has some value in the management of refractory RSD pain in selected cases. Because of the limited series and follow-up, its value in the comprehensive management of RSD requires further investigation.
Percutaneous epidural stimulation of the spinal cord for relief of pain. Long-term results. [2004]Percutaneous epidural stimulation of the spinal cord was carried out in 20 patients with intractable pain. The procedure proved simple, and no major complications were encountered. The long-term results were comparable to the results obtained after a dorsal column stimulator implant by laminectomy. The percutaneous technique allowed extended trial stimulation without committing the patient to a major operation. Those patients in whom stimulation did not alleviate pain could be identified during a 2-week observation period, and the system could be removed easily. Seven patients were placed on chronic autostimulation and only one of those failed to experience continuing pain relief throughout the follow-up time of up to 2 years. It is concluded that percutaneous epidural stimulation constitutes a valid alternative to dorsal column stimulator implantation.
[Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines]. [2021]Epidural spinal cord stimulation (SCS) is a reversible but invasive procedure which should be used for neuropathic pain, e.g. complex regional pain syndrome I (CRPS) and for mostly chronic radiculopathy in connection with failed back surgery syndrome following unsuccessful conservative therapy. Epidural SCS can also successfully be used after exclusion of curative procedures and conservative therapy attempts for vascular-linked pain, such as in peripheral arterial occlusive disease stages II and III according to Fontaine and refractory angina pectoris. Clinical practice has shown which clinical symptoms cannot be successfully treated by epidural SCS, e.g. pain in complete paraplegia syndrome or atrophy/injury of the sensory pathways of the spinal cord or cancer pain. A decisive factor is a critical patient selection as well as the diagnosis. Epidural SCS should always be used within an interdisciplinary multimodal therapy concept. Implementation should only be carried out in experienced therapy centers which are in a position to deal with potential complications.
Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience. [2011]Epidural spinal cord stimulation by means of chronically implanted electrodes was carried out on 121 patients with pain of varied benign organic etiology. In 116 patients, the pain was confined to the back and lower extremities and, of these, 56 exhibited the failed-back syndrome. Most patients were referred by a pain management service because of failure of conventional pain treatment modalities. Electrodes were implanted at varying sites, dictated by the location of pain. A total of 140 epidural implants were used: 76 unipolar, 46 Resume electrodes, 12 bipolar, and six quadripolar. Patients were followed for periods ranging from 6 months to 10 years, with a mean follow-up period of 40 months. Forty-eight patients (40%) were able to control their pain by neurostimulation alone. A further 14 patients (12%), in addition to following a regular stimulation program, needed occasional analgesic supplements to achieve 50% or more relief of the prestimulation pain. Pain secondary to arachnoiditis or perineural fibrosis following multiple intervertebral disc operations, when predominantly confined to one lower extremity, seemed to respond favorably to this treatment. Uniformly good results were also obtained in lower-extremity pain secondary to multiple sclerosis. Pain due to advanced peripheral vascular disease of the lower limbs was well controlled, and amputation below the knee was delayed for up to 2 years in some patients. Pain due to cauda equina injury, paraplegic pain, phantom-limb pain, pure midline back pain without radiculopathy, or pain due to primary bone or joint disease seemed to respond less well. Patients who responded to preliminary transcutaneous electrical nerve stimulation generally did well with electrode implants. Notable complications included wound infection, electrode displacement or fracturing, and fibrosis at the stimulating tip of the electrode. Three patients in this series died due to unrelated causes. Epidural spinal cord stimulation has proven to be an effective and safe means of controlling pain on a long-term basis in selected groups of patients. The mechanism of action of stimulation-produced analgesia remains unclear; further studies to elucidate it might allow spinal cord stimulation to be exploited more effectively in disorders that are currently refractory to this treatment modality.
Alternate Intraspinal Targets for Spinal Cord Stimulation: A Systematic Review. [2022]Conventional dorsal column spinal cord stimulation (SCS) provides less than optimal pain relief for certain pain syndromes and anatomic pain distributions. Practitioners have sought to treat these challenging therapeutic areas with stimulation of alternate intraspinal targets.
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]Spinal cord stimulation (SCS) has been proven effective for multiple chronic pain syndromes. Over the past 40 years of use, the complication rates of SCS have been well defined in the literature; however, the incidence of one of the most devastating complications, spinal cord injury (SCI), remains largely unknown. The goal of the study was to quantify the incidence of SCI in both percutaneous and paddle electrode implantation.
Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]Spinal cord stimulation (SCS) is an established therapy for refractory neuropathic pain. To ascertain the balance between treatment benefits and risks, the French National Authority for Health requested a post-market registry for real-world evaluation of the long-term effectiveness and safety of the therapy.
The Aarhus Neuromodulation Database. [2022]ΒΒ Spinal cord stimulation (SCS) is increasingly gaining widespread use as a treatment for chronic pain. A widely used electronic registry could play a pivotal role in improving this complex and cost-ΒΒintensive treatment. We aimed to construct a comprehensive, universally available data base for SCS.
A report of paraparesis following spinal cord stimulator trial, implantation and revision. [2011]Spinal cord injury has been reported as a rare complication of spinal cord stimulation (SCS). A review of the literature shows a very low incidence of neurological injury after spinal cord stimulation trial, implantation and revision. The most common reported complication is equipment failure without neurologic injury. The incidence of spinal cord injury after SCS trial, implantation and revision is unknown. There have been limited reports of neurologic injury secondary to dural puncture, infection, cord contusion, actual needle penetration of the spinal cord and epidural hematoma.
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.
Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study. [2021]Spinal cord stimulation (SCS) activates the dorsal column fibers using electrical stimuli. Current SCS systems function in fixed-output mode, delivering the same stimulus regardless of spinal cord (SC) activation.
Successful spinal cord stimulation for neuropathic below-level spinal cord injury pain following complete paraplegia: a case report. [2019]Neuropathic pain is common in patients with spinal cord injury (SCI) and often difficult to treat. We report a case where epidural spinal cord stimulation (SCS) below the level of injury has been successfully applied in a patient with a complete spinal cord lesion.
Beyond treatment of chronic pain: a scoping review about epidural electrical spinal cord stimulation to restore sensorimotor and autonomic function after spinal cord injury. [2023]Epidural electrical epinal cord stimulation (ESCS) is an established therapeutic option in various chronic pain conditions. In the last decade, proof-of-concept studies have demonstrated that ESCS in combination with task-oriented rehabilitative interventions can partially restore motor function and neurological recovery after spinal cord injury (SCI). In addition to the ESCS applications for improvement of upper and lower extremity function, ESCS has been investigated for treatment of autonomic dysfunction after SCI such as orthostatic hypotension. The aim of this overview is to present the background of ESCS, emerging concepts and its readiness to become a routine therapy in SCI beyond treatment of chronic pain conditions.