Spinal Cord Stimulation for Phantom Limb Pain
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
Disqualifiers: Open wounds, Metal rods, Defibrillator, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this project is to characterize the types of sensations that can be evoked via electrical stimulation of the spinal cord and spinal nerves. Patients will be recruited from a local pain clinic, each with a spinal cord stimulation device implanted, to participate in experiments to explore the ability to modulate and control the modality, intensity, focality, and location of the sensations evoked by stimulation through the spinal cord stimulator leads. Investigators will connect spinal cord stimulator leads to a custom stimulator system and will ask subjects to report the types of sensations felt. Invesigators will also perform detailed psychophysical metrics to examine participants' ability to discriminate sensations.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Spinal Cord Stimulation for Phantom Limb Pain?
Spinal Cord Stimulation (SCS) has shown promise in reducing phantom limb pain, with some studies reporting good to excellent pain relief in most patients. For example, one study noted significant pain reduction in a patient using SCS, with pain scores dropping from 8/10 to 2/10, although some pain returned over time.
12345Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation (SCS) is generally considered safe for humans, with studies showing a low rate of serious complications. In a global study, the most common serious issue was implant site infection, occurring in less than 1% of cases, and the overall rate of device removal due to problems was low.
678910How does spinal cord stimulation differ from other treatments for phantom limb pain?
Spinal cord stimulation (SCS) is unique because it involves implanting a device that delivers electrical pulses to the spinal cord, which can help reduce pain by altering nerve activity. Unlike traditional pain medications, SCS directly targets the nervous system and can be effective when other treatments fail.
13111213Eligibility Criteria
This trial is for individuals aged 18-70 with Phantom Limb Syndrome or similar conditions, who are already part of a pain management clinical trial involving an epidural spinal cord stimulator. Participants must understand the consent process and procedures.Inclusion Criteria
I am part of Dr. Helm's clinical trial for pain management using an epidural spinal cord electrode.
Persons must understand the consent and the procedures.
I am between 18 and 70 years old.
Exclusion Criteria
You have permanent metal tags or decorations on your skin.
You have metal rods in your spine or limbs.
You have a defibrillator or pacemaker.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Stimulation Trials
Participants undergo psychophysical stimulation trials with an external stimulator connected to the SCS lead to characterize sensory responses.
2 days
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after stimulation trials
2 weeks
Participant Groups
The study tests how different sensations can be created by electrically stimulating the spinal cord using implanted devices. It aims to control sensation type, intensity, and location through these devices while participants report their experiences.
1Treatment groups
Experimental Treatment
Group I: Stimulation in individuals with implanted stimulation systemsExperimental Treatment1 Intervention
During psychophysical stimulation trials, an external stimulator will be connected to the SCS lead, a volley of stimulation will be performed, and the subject will be asked to respond to standard psychophysical questions, as well as to provide any additional comments.
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
References
Use of spinal cord stimulation in the treatment of phantom limb pain: case series and review of the literature. [2022]Despite technical advances in spinal cord stimulation (SCS), there is a paucity of recent literature regarding SCS for phantom limb pain.
Complete coverage of phantom limb and stump pain with constant current SCS system: a case report and review of the literature. [2018]Spinal cord stimulator (SCS) technology has advanced over the past several years. However, our literature review revealed a lack of well-documented cases of successful treatment of phantom limb pain with percutaneous revision of previously placed systems.
Spinal Cord Stimulation in The Treatment of Phantom Limb Pain: A Case Report and Review of Literature. [2022]Phantom limb pain is a form of chronic neuropathic pain by which 50-80% of the amputees feel the pain that is not adequately controlled by analgesics. When pain management through pharmacological treatment alone is unsuccessful, surgical treatment options are proven to be effective. We report a case of 61-year-old man who sought consultation with phantom limb pain after his motor vehicular accident and below elbow amputation three years before the consultation. His pain was not relieved by analgesics alone and opted for spinal cord stimulation. Chronic Dual Channel dorsal column stimulation was done using Medtronic Prime Advance SCS System. He was in good pain relief and his VAS decreased from (8/10) to (2/10) but since the last six months follow-up he is complaining of pain again (4/10) for which he is taking analgesics too.
The Challenge of Converting "Failed Spinal Cord Stimulation Syndrome" Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study. [2022]While paresthesia-based Spinal Cord Stimulation (SCS) has been proven effective as treatment for chronic neuropathic pain, its initial benefits may lead to the development of "Failed SCS Syndrome' (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neurostimulation adapters, in patients already implanted with SCS and experiencing LoE. We retrospectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before and at 1-, 3-, 6- and 12-month follow-ups. Outcomes included pain intensity rating with a Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N = 27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and quality of life (p = 0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompanied via paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conversion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled via spatial retargeting. In light of these results, adapters could be integrated in SCS rescue algorithms or should be considered in SCS rescue.
Phantom limb pain. Treatment with dorsal column stimulation. [2007]Good to excellent relief of phantom pain is reported in 5 of 6 patients by the use of dorsal column stimulation. Follow-up periods are 7 to 25 months. One failure occurred despite excellent pain relief; this patient could not tolerate application of the DCS apparatus to his chest wall. The authors review the physiology involved and some less successful series reported by others.
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.
The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. [2022]Background. Spinal cord stimulation (SCS) is effective in reducing pain from a number of differing medical conditions that are refractory to other, more conservative treatments. Much is written in the literature regarding efficacy and safety of SCS; however, no one to our knowledge has compared and reported safety and efficacy of SCS when using differing manufactured SCS devices. We undertook such a preliminary evaluation. Methods. Charts from the years 2001-2005 of our clinic's patients who had undergone trials and placement of permanent SCS systems were selected for review. All patients who had received either an Advanced Bionics SCS system (Advanced Bionics, Valencia, CA, USA), an Advanced Neuromodulation Systems (ANS) SCS system (ANS, Plano, TX, USA), or a Medtronic SCS system (Medtronic, Inc., Minneapolis, MN, USA) were given a survey to complete for data analysis. Patients were categorized into three groups: those patients having received a Medtronic (Mdt) SCS system, those patients having received an Advance Bionics (ABi) SCS system, and those patients having received an Advance Neuromodulation Systems (ANS) SCS system. Data, limited to volunteers, who gave their written consent, were analyzed for efficacy and complications. Differences in outcomes and safety were analyzed overall and according to manufacturer. Results. Eighty surveys were mailed out to 80 patients and 30 surveys were completed and returned, a return and completion rate of 37.5%. All patients showed improvement in all aspects including pain relief, sleep, functional activities, and medication use for pain control. When comparing outcomes of SCS from the three different companies, there was no significant statistical difference in average percentage pain relief, sleep improvement, and medication needed for pain control. However, there was a statistically different less change in functional improvement in the ABi group when compared to patients in the Mdt and ANS groups. Conclusions. Spinal cord stimulation improves pain, sleep, and function in patients with intractable pain. Because of the low number of patients evaluable in this study, we believe that conclusions should not be made regarding the effect of technology on outcomes or safety. We believe that an analysis of this type in larger populations is warranted to understand the role, if any, that present-day technology has on outcomes of SCS.
Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).
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: Background and clinical application. [2022]Background Spinal cord stimulation (SCS) is a surgical treatment for chronic neuropathic pain refractory to conventional treatment. SCS treatment consists of one or more leads implanted in the epidural space of the spinal canal, connected to an implantable pulse generator (IPG). Each lead carries a number of contacts capable of delivering a weak electrical current to the spinal cord, evoking a feeling of peripheral paresthesia. With correct indication and if implanted by an experienced implanter, success rates generally are in the range of about 50-75%. Common indications include complex regional pain syndrome (CRPS I), angina pectoris, and radicular pain after failed back surgery syndrome, and the treatment is also used to treat stump pain after amputation, and pain due to peripheral nerve injury, peripheral vascular disease, and diabetic neuropathy. Recommended contraindications for the treatment include pregnancy, coagulopathy, severe addiction to psychoactive substances, and lack of ability to cooperate (e.g. due to active psychosis or cognitive impairment). Most common complications to the treatment include lead migration, lead breakage, infection, pain over the implant, and dural puncture. Despite extensive research in the area, the mechanisms of action are still only partially understood. Methods In this topical review the historical background behind the treatment is described and the current theories on the mechanism of action are presented. The implantation procedure is described in detail and illustrated with a series of intraoperative pictures. Finally, indications for SCS are discussed along with some of the controversies surrounding the therapy. Implications The reader is presented with a broad overview of spinal cord stimulation, including the historical and theoretical background, practical implantation technique, and clinical application.
Efficacy of the latest new stimulation patterns of spinal cord stimulation for intractable neuropathic pain compared to conventional stimulation: study protocol for a clinical trial. [2023]Spinal cord stimulation (SCS) is one of the neuromodulation therapies for chronic neuropathic pain. The conventional paresthesia-based SCS involves the application of tonic stimulation that induces a sense of paresthesia. Recently, new SCS stimulation patterns without paresthesia have been developed. Differential target multiplexed (DTM) stimulation and fast-acting subperception therapy (FAST) stimulation are the latest paresthesia-free SCS patterns.
Spinal cord stimulation in deafferentation pain. [2018]Spinal cord stimulation (SCS) was used in 49 cases to control resistant deafferentation pain resulting from causalgia, phantom limb, plexus and nerve root avulsion, postherpetic neuralgia, reflex sympathetic dystrophy and amputation. In all cases, one or two standard percutaneous leads were introduced into the epidural space and manipulated until the spinal segment at which external stimulation provoked paresthesic sensation in the painful area. Two weeks of external stimulation trial was used to determine the efficiency of the system. Pulse width of 0.1-0.2 ms, a rate of 80-120 cps and amplitude to low paresthesia threshold were programmed as electric parameters. In 36 out of the 49 tested cases showing a positive response to percutaneous SCS, the device was permanently implanted. After a mean follow-up of 5.5 years, 57% of patients had satisfactory pain relief (over 75%). Side effects were limited to dislodgement of the electrode in 1 case and wire extrusion in another, both requiring replacement of the stimulator.