Trial Summary
What is the purpose of this trial?This study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.
Is Spinal Cord Epidural Stimulation a promising treatment for spinal cord injury?Yes, Spinal Cord Epidural Stimulation is a promising treatment for spinal cord injury. It has shown success in managing chronic pain and improving motor function by reactivating spinal circuits. Many patients have experienced significant pain relief and improved motor abilities, making it a valuable option for those with spinal cord injuries.124610
What safety data is available for spinal cord epidural stimulation?Safety data for spinal cord epidural stimulation, also known as spinal cord stimulation (SCS), indicates that while it is effective for chronic pain, complications can occur. The most common issues are equipment failure and surgical site infections. Neurological injuries, such as spinal cord injury, are rare but have been reported due to factors like dural puncture, infection, and epidural hematoma. Long-term safety data from registries show a balance between benefits and risks, but less common neurological effects like tinnitus and vertigo have also been noted. Further research is needed to fully understand these risks.35789
What data supports the idea that Spinal Cord Epidural Stimulation for Spinal Cord Injury is an effective treatment?The available research shows that Spinal Cord Epidural Stimulation can help improve movement and other body functions after a spinal cord injury. One study found that it can restore voluntary movement and improve body functions in people with spinal cord injuries from gunshots. Another study suggests that it can help with movement and recovery when combined with specific exercises. While it is mainly used for pain relief, these studies indicate it can also help with spinal cord injuries.14111213
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you have an implanted pump, you cannot participate.
Eligibility Criteria
This trial is for adults with spinal cord injuries who have issues with bladder and bowel control. Participants must use intermittent catheterization and not be pregnant, ventilator-dependent, or have a colostomy bag. They shouldn't have had certain bladder treatments like Botox injections or surgery.Inclusion Criteria
I have issues controlling my bladder and bowel due to nerve problems.
I have issues controlling my bladder and bowel due to nerve problems.
I am 18 years old or older.
I am 18 years old or older.
Exclusion Criteria
I have had Botox injections in my bladder or bladder surgery before.
I use a colostomy bag.
Treatment Details
The study tests how well spinal cord epidural stimulation can manage high blood pressure and improve bladder and sexual function after injury. It involves controlled lab assessments and at-home monitoring to evaluate the therapy's effectiveness.
2Treatment groups
Experimental Treatment
Active Control
Group I: Cardiovascular spinal cord epidural stimulationExperimental Treatment1 Intervention
The purpose of this arm is to use spinal cord epidural stimulation for maintenance of blood pressure and heart rate in the lab during cystometry (bladder filling) and anorectal filling (bowel distension) and in the at-home setting for maintenance of normative blood pressure and heart rate that can be triggered from bladder filling and during bowel evacuation.
Group II: Measure symptomatic indices of autonomic dysreflexiaActive Control1 Intervention
The purpose of this arm is to systematically measure symptomatic indices of autonomic nervous system activation and corresponding cardiovascular changes in persons with spinal cord injuries during bladder filling and bowel stimulation.
Spinal Cord Epidural Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Spinal Cord Stimulation for:
- Respiratory dysfunction in spinal cord injury
- Pain management
🇪🇺 Approved in European Union as Epidural Spinal Cord Stimulation for:
- Chronic pain
- Respiratory complications in spinal cord injury
🇨🇦 Approved in Canada as Electrical Spinal Cord Stimulation for:
- Spinal cord injury rehabilitation
- Neuropathic pain
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of LouisvilleLouisville, KY
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Who is running the clinical trial?
University of LouisvilleLead Sponsor
National Institutes of Health (NIH)Collaborator
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.
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.
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.
Postsurgical pathologies associated with intradural electrical stimulation in the central nervous system: design implications for a new clinical device. [2022]Spinal cord stimulation has been utilized for decades in the treatment of numerous conditions such as failed back surgery and phantom limb syndromes, arachnoiditis, cancer pain, and others. The placement of the stimulating electrode array was originally subdural but, to minimize surgical complexity and reduce the risk of certain postsurgical complications, it became exclusively epidural eventually. Here we review the relevant clinical and experimental pathologic findings, including spinal cord compression, infection, hematoma formation, cerebrospinal fluid leakage, chronic fibrosis, and stimulation-induced neurotoxicity, associated with the early approaches to subdural electrical stimulation of the central nervous system, and the spinal cord in particular. These findings may help optimize the safety and efficacy of a new approach to subdural spinal cord stimulation now under development.
Evaluation of optimal electrode configurations for epidural spinal cord stimulation in cervical spinal cord injured rats. [2018]Epidural spinal cord stimulation is a promising technique for modulating the level of excitability and reactivation of dormant spinal neuronal circuits after spinal cord injury (SCI). We examined the ability of chronically implanted epidural stimulation electrodes within the cervical spinal cord to (1) directly elicit spinal motor evoked potentials (sMEPs) in forelimb muscles and (2) determine whether these sMEPs can serve as a biomarker of forelimb motor function after SCI.
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.
New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. [2020]The most common complications of spinal cord stimulation (SCS) therapy are generally related to surgical site infection and hardware malfunction. Less well understood are the adverse neurological effects of this therapy. We present the case of a patient who underwent placement of a Senza HF10 high-frequency spinal cord stimulator with subsequent development of tinnitus, vertigo, intermittent involuntary left facial twitches, and perioral numbness. These symptoms resolved following deactivation of her device. To further explore these less common neurologic complications of SCS therapy, a review of literature and a review of the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database are included. Further research and investigation in this area are needed so that clinicians and patients may have more complete knowledge and understanding of the potential treatment-limiting complications of spinal cord stimulation.
Epidural spinal cord stimulation for motor recovery in spinal cord injury: A systematic review. [2021]Epidural spinal cord stimulation (ESCS) emerged as a technology for eliciting motor function in the 1990's and was subsequently employed therapeutically in the population with spinal cord injury (SCI). Despite a considerable number of ESCS studies, a comprehensive systematic review of ESCS remains unpublished.
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.
Recovery of volitional movement with epidural stimulation after "complete" spinal cord injury due to gunshot: A case report and literature review. [2023]Epidural spinal cord stimulation (eSCS) restores volitional movement and improves autonomic function after nonpenetrating and traumatic spinal cord injury (SCI). There is limited evidence of its utility for penetrating SCI (pSCI).
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.