Trial Summary
What is the purpose of this trial?This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
Is the treatment Epidural Spinal Cord Stimulation promising for spinal cord injury?Yes, Epidural Spinal Cord Stimulation is promising for spinal cord injury. It has been shown to help manage chronic pain and improve movement in people with severe spinal cord injuries. Many patients have experienced good results, and it can delay more serious procedures like amputation. It also helps with posture and walking in some cases.13469
What safety data exists for epidural stimulation in spinal cord injury treatment?The safety data for spinal cord stimulation (SCS), including epidural stimulation, indicates that it is generally considered a safe treatment for conditions like chronic pain and complex regional pain syndrome. Complications such as equipment failure are more common than neurological injuries. However, rare complications like spinal cord injury, dural puncture, infection, and epidural hematoma have been reported. The incidence of spinal cord injury specifically related to SCS is not well defined, but it is considered rare. Techniques for safe removal of SCS paddle leads are still being refined, and long-term safety data is being collected through registries to better understand the balance of benefits and risks.57101112
What data supports the idea that Epidural Stimulation for Spinal Cord Injury is an effective treatment?The available research shows that Epidural Stimulation can lead to multiple functional improvements in people with spinal cord injuries, as highlighted in a case report. Additionally, while primarily used for pain management in other conditions, such as reflex sympathetic dystrophy and chronic pain, Epidural Stimulation has been effective in providing pain relief for many patients. For instance, in a study with 121 patients, 40% were able to control their pain using this treatment alone, and another 12% achieved significant pain relief with occasional additional medication. This suggests that Epidural Stimulation can be a valuable treatment option for managing symptoms associated with spinal cord injuries.126813
Do I have to stop taking my current medications?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you need opioid pain medications or have used Botox injections in the last six months.
Eligibility Criteria
This trial is for adults over 22 with stable spinal cord injuries, who are not ventilator-dependent and have an existing, working FDA-approved spinal cord stimulator. They should be medically stable and at least a year out from their initial injury. Those with certain levels of impairment (AISA 'A' or 'B'), no recent Botox treatments, and not on opioid pain meds that would limit rehab participation can join.Treatment Details
The study tests the long-term effects of chronic epidural spinal cord stimulation in restoring voluntary movement in patients with chronic spinal cord injuries. It aims to understand how this treatment helps over time.
1Treatment groups
Experimental Treatment
Group I: Volitional EMG powerExperimental Treatment1 Intervention
Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.
Epidural Spinal Cord Stimulation is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Spinal Cord Stimulation for:
- Failed back surgery syndrome
- Complex regional pain syndrome
- Chronic neuropathic pain
- Ischemic pain
🇺🇸 Approved in United States as Spinal Cord Stimulation for:
- Failed back surgery syndrome
- Complex regional pain syndrome
- Chronic neuropathic pain
- Ischemic pain
- Diabetic neuropathy
🇨🇦 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
References
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.
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.
Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. [2019]Epidural electrical stimulation of the spinal cord by means of percutaneously implanted electrodes was successfully used in cases of traumatic paraplegia with chronic pain, more particularly if vegetative components predominated. Out of seven patients treated in our clinic six reported a good or very good outcome of the stimulation over follow-up periods up to six years. On account of the good effect on chronic pain the use of this stimulation procedure is indicated and justified before considering any destructive operative measures.
Epidural stimulation: comparison of the spinal circuits that generate and control locomotion in rats, cats and humans. [2022]Although epidural stimulation is a technique that has been used for a number of years to treat individuals with a spinal cord injury, the intended outcome has been to suppress plasticity and pain. Over the last decade considerable progress has been made in realizing the potential of epidural stimulation to facilitate posture and locomotion in subjects with severe spinal cord injury who lack the ability to stand or to step. This progress has resulted primarily from experiments with mice, rats and cats having a complete spinal cord transection at a mid-thoracic level and in humans with a complete spinal cord injury. This review describes some of these experiments performed after the complete elimination of supraspinal input that demonstrates that the circuitry necessary to control remarkably normal locomotion appears to reside within the lumbosacral region of the spinal cord. These experiments, however, also demonstrate the essential role of processing proprioceptive information associated with weight-bearing stepping or standing by the spinal circuitry. For example, relatively simple tonic signals provided to the dorsum of the spinal cord epidurally can result in complex and highly adaptive locomotor patterns. Experiments emphasizing a significant complementary effect of epidural stimulation when combined with pharmacological facilitation, e.g., serotonergic agonists, and/or chronic step training also are described. Finally, a major point emphasized in this review is the striking similarity of the lumbosacral circuitry controlling locomotion in the rat and in the human.
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.
[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.
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.
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.
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.
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.
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.
Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. [2022]Spinal cord stimulation (SCS) is a safe neuromodulatory treatment used to treat failed back surgery syndrome, chronic neuropathic pain, and complex regional pain syndrome. Despite its efficacy, some patients fail to achieve pain relief and elect to undergo removal of SCS paddle leads. The safety and best practices of these procedures have not been defined.
Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. [2023]There is a revived interest to explore spinal cord epidural stimulation (SCES) to improve physical function after spinal cord injury (SCI). This case report highlights the potential of eliciting multiple functional improvements with a single SCES configuration, a strategy which could improve clinical translation.