Epidural Electrical Stimulation for Spinal Cord Disorders
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.
How is Epidural Electrical Stimulation different from other treatments for spinal cord disorders?
Epidural Electrical Stimulation (EES) is unique because it involves implanting electrodes to stimulate the spinal cord, which can help improve mobility and reduce pain in conditions like chronic pain and spasticity when other treatments fail. Unlike some treatments that may involve medication or surgery, EES is a reversible and minimally invasive procedure that directly targets the spinal cord to modulate nerve activity.
24568Is epidural electrical stimulation generally safe for humans?
Epidural electrical stimulation has been used for decades and is considered a minor procedure, but it can have complications like broken or moved electrodes, spinal cord compression, infection, and other issues. These risks are known and efforts are made to minimize them.
35789What data supports the effectiveness of the treatment Epidural Electrical Stimulation for spinal cord disorders?
Research shows that Epidural Electrical Stimulation (EES) can improve mobility and reduce spasticity (muscle stiffness) in patients with conditions like multiple sclerosis and myelopathy. It has also been effective in managing chronic pain in patients with spinal cord injuries and other conditions, providing significant pain relief for many individuals.
12345Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
This trial is for patients who are undergoing brain or spinal cord surgery and where monitoring of the spinal cord's activity is used. There are no specific exclusion criteria, so it appears open to all eligible surgical candidates.Inclusion Criteria
I am having brain or spinal surgery with monitoring.
Participant Groups
The study tests if epidural electrical stimulation (EES) at the cervical spine can counteract opioid-induced breathing problems during surgery. It will record how EES affects motor activity and respiratory function in human patients.
1Treatment groups
Experimental Treatment
Group I: Electrical Stimulation groupExperimental Treatment1 Intervention
Epidural Electrical Stimulation of the Cervical Spinal Cord
Epidural Electrical Stimulation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Spinal Cord Stimulation for:
- Chronic pain management
- Failed back syndrome
- Complex regional pain syndrome
🇪🇺 Approved in European Union as Epidural Electrical Stimulation for:
- Chronic pain management
- Neuropathic pain
- Ischemic pain
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of California, Los AngelesLos Angeles, CA
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
References
Epidural spinal electrical stimulation in the treatment of severe arterial occlusive disease. [2019]The effect of epidural spinal cord stimulation (ESES) on peripheral circulation in 10 cases with advanced vascular occlusive disease has been tested, using transcutaneous oxygen measurement (TcpO2), contact thermography and laser-speckle measurements. The values in all cases increased. Improvement was more pronounced during the first 2-3 weeks. Indications and limitations of this treatment modality are discussed.
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.
[Cervical epidural spinal cord stimulation in infantile encephalopathy]. [2007]The effect of Cervical Epidural Spinal cord Electrical Stimulation (E.S.E.S.) was studied in 15 patients with cerebral palsy. Spasticity and dyskinesia, daily functioning and the emotional and physical burden of this therapy for the patients were examined. Twelve patients did not continue the treatment after completing the study, because of lack of symptomatic or functional improvement and many complications due to broken or migrated electrodes. Two patients still continue E.S.E.S. and a third is awaiting replacement of a broken electrode. None of these three patients showed a clear improvement of the ADL scale or the disability score. E.S.E.S. cannot be recommended as a symptomatic treatment for cerebral palsy patients.
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 spinal electrostimulation (ESES) in patients with chronic pain and central motor disturbances (author's transl)]. [2006]Epidural spinal electrostimulation (ESES), as method in the treatment of patients with chronic pain or severe central motor disturbances, especially spastic paresis of spinal origin and bladder dysfunction, is indicated when conservative measures prove ineffectual and before surgical intervention is considered. The biochemical and innervation processes which are brought about by ESES are discussed, as well as the literature on the efficacy and possible complications of the method. Twenty cases were subjected to a test stimulation and in twelve of these the stimulation system was implanted. Spinal spasticity and the range of mobility were improved by 20 to 30% in 8 patients with multiple sclerosis and 3 other patients with myelopathy of varied aetiology. In addition, spastic cramps of abrupt onset, with or without pain, disappeared almost completely following ESES in all cases. Three cases with chronic pain, two after a caudal lesion and one with cervical radicular damage, were markedly improved.
[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.
Characterization and applications of evoked responses during epidural electrical stimulation. [2023]Epidural electrical stimulation (EES) of the spinal cord has been FDA approved and used therapeutically for decades. However, there is still not a clear understanding of the local neural substrates and consequently the mechanism of action responsible for the therapeutic effects.
Anticipating and preventing complications in spinal cord stimulator implantation. [2023]Spinal cord stimulation is considered a minor elective procedure. The inherent goal is to provide safe, reliable, effective treatment with mitigation of known potential risk of adverse events.