Spinal Cord Stimulation for Lower Extremity Amputation (SCS-90 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Lee Fisher, PhD
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal nerves convey sensory information from peripheral nerves to higher order centers in the brain. These structures still remain intact after amputation and electrical stimulation of the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated to generate paresthetic sensory percepts referred to portions of the distal limb. Further, there is recent evidence that careful modulation of stimulation parameters can convert paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in amputees. However, it is currently unclear whether it is possible to achieve this same conversion when stimulating the spinal nerves, and if those naturalistic sensations can have positive effects on phantom limb pain. As a first step towards those goals, in this study, the investigators will quantify the sensations generated by electrical stimulation of the spinal nerves, study the relationship between stimulation parameters and the quality of those sensations, measure changes in control of a prosthesis with sensory stimulation, and quantify the effects of that stimulation on the perception of the phantom limb and any associated pain.
Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation (SCS) is generally considered safe for humans, as it is a reversible treatment used for various conditions like chronic pain and critical limb ischemia. However, specific risks and complications can occur, such as those related to electrode placement and removal, which need to be managed by healthcare professionals.
24567What data supports the effectiveness of the treatment Spinal Cord Stimulation for lower extremity amputation?
Research shows that spinal cord stimulation (SCS) has been used since the 1970s to relieve chronic pain after limb amputation, and it has been successful in many cases. Additionally, transcutaneous spinal cord stimulation (tSCS) has shown promise in improving muscle movement and strength in people with spinal cord injuries, suggesting potential benefits for other conditions affecting the lower limbs.
13567Will 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 participate if you are taking medications that affect blood coagulation or are receiving immunosuppressive medications.
How is spinal cord stimulation different from other treatments for lower extremity amputation?
Spinal cord stimulation (SCS) is unique because it uses electrical pulses to relieve chronic pain by targeting the spinal cord, which is different from typical pain medications that work throughout the body. This treatment is particularly useful when other options, like surgery, are not possible or have failed.
23567Eligibility Criteria
This trial is for lower-limb amputees aged 22-70 who are at least six months post-amputation, have been using their current prosthesis for over six months, and can walk with or without support. Pregnant women, those on blood thinners, with severe diseases, allergies to MRI contrast agents or renal failure, high hemoglobin A1c levels (>8.0 mg/dl), implanted devices not cleared for MRI (like pacemakers), immunosuppressed individuals or those in radiation-heavy professions cannot join.Inclusion Criteria
I am between 22 and 70 years old.
I've used my current prosthesis for 6+ months and can walk with it.
Exclusion Criteria
I am not taking any blood-thinning medications.
I am not pregnant or breastfeeding.
I don't have allergies to MRI dyes or severe kidney problems.
Participant Groups
The study tests a spinal cord stimulator designed to provide sensory feedback and reduce phantom limb pain in lower-limb amputees. It aims to understand how electrical stimulation of the spinal nerves affects sensation quality and prosthetic control while also measuring its impact on phantom limb perception and associated pain.
1Treatment groups
Experimental Treatment
Group I: Spinal cord stimulationExperimental Treatment1 Intervention
Spinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation.
Participants in this study receive spinal cord stimulation will be trans-tibial amputees that are at least six month post--amputation. Subjects will have varying levels of phantom limb sensation and pain, but should have no other significant neurological disorders.
Spinal cord stimulator is already approved in United States, European Union for the following indications:
๐บ๐ธ Approved in United States as Spinal Cord Stimulation for:
- Chronic pain
- Phantom limb pain
- Neuropathic pain
๐ช๐บ Approved in European Union as Spinal Cord Stimulation for:
- Chronic pain
- Phantom limb pain
- Neuropathic pain
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of PittsburghPittsburgh, PA
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Who is running the clinical trial?
Lee Fisher, PhDLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Improvement of limb circulation in peripheral vascular disease using epidural spinal cord stimulation: a prospective study. [2013]Spinal cord stimulation was used in 46 patients for pain associated with lower extremity ischemic vascular disease that was considered to be nonreconstructable. Thirty-nine patients who had a follow-up examination between 2 and 36 months after the procedure form the basis of this report. Thirty (77%) of 39 cases were considered successful. Clinical endpoints indicating failure included amputation, vascular reconstruction, poor pain relief, or hardware malfunction. The transcutaneous partial pressure of oxygen (TcPO2) increased in both target and control feet. In patients with good outcome with a preimplantation TcPO2 of less than 30 mm Hg, TcPO2 increased significantly (p
Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. [2019]Electrical spinal cord stimulation (ESCS) is a technique for the management of chronic painful diabetic neuropathy (CPDN) affecting the lower limbs. We assessed the efficacy and complication rate of ESCS implanted at least 7 years previously in eight patients.
Spinal cord stimulation for intractable pain following limb amputation. [2022]ยย Spinal cord stimulation (SCS) by high-frequency electrical pulses has been used since the early 1970s for relief of chronic intractable pain following limb amputation. The long-ยยterm effectiveness of SCS for amputation-ยยrelated pain with ongoing after-care is reviewed by assessment of all such cases managed over 20 years in the Neurostimulator Clinic at the Royal London Hospital.
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.
Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]Background. Epidural spinal electrical stimulation at the lumbar spinal level evokes rhythmic muscle activation of lower-limb antagonists, attributed to the central pattern generator. However, the efficacy of noninvasive spinal stimulation for the activation of lower-limb muscles is not yet clear. This review aimed to analyze the feasibility and efficacy of noninvasive transcutaneous spinal cord stimulation (tSCS) on motor function in individuals with spinal cord injury. Methods. A search for tSCS studies was made of the following databases: PubMed; Cochrane Registry; and Physiotherapy Evidence Database (PEDro). In addition, an inverse manual search of the references cited by the identified articles was carried out. The keywords transcutaneous, non-invasive, electrical stimulation, spinal cord stimulation [Mesh term], and spinal cord injury were used. Results. A total of 352 articles were initially screened, of which 13 studies met the inclusion criteria for systematic review. The total participant sample comprised 55 persons with spinal cord injury. All studies with tSCS provided evidence of induced muscle activation in the lower and upper limbs, and applied stimulation at the level of the T11-T12 and C4-C7 interspinous space, respectively. All studies reported an increase in motor response measured by recording surface electromyography, voluntary movement, muscle strength, or function. Conclusions. Although this review highlights tSCS as a feasible therapeutic neuromodulatory strategy to enhance voluntary movement, muscle strength, and function in patients with chronic spinal cord injury, the clinical impact and efficacy of electrode location and current intensity need to be characterized in statistically powered and controlled clinical trials.
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]Transcutaneous spinal cord stimulation (tSCS) is a non-invasive modality in which electrodes can stimulate spinal circuitries and facilitate a motor response. This review aimed to evaluate the methodology of studies using tSCS to generate motor activity in persons with spinal cord injury (SCI) and to appraise the quality of included trials.
Spinal cord stimulation in non-reconstructable critical limb ischemia: a retrospective study of 71 cases. [2023]Spinal cord stimulation (SCS) is a therapeutic option for patients with a peripheral arterial disease with critical limb ischemia (CLI) and consequent ischemic rest pain. Neuromodulation is chosen when vascular reconstruction is not possible or failed. Data about the effect of SCS over limb salvage rates are dissonant.