Spinal Cord Stimulation for Peripheral Neuropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether spinal cord stimulation (SCS) can reduce pain and improve quality of life for individuals with chemotherapy-induced peripheral neuropathy (CIPN), a condition causing pain, numbness, or weakness in the hands or feet after chemotherapy. SCS has proven effective for other nerve pain conditions, and researchers aim to determine its effectiveness for CIPN. Participants will receive SCS treatment and complete questionnaires about their pain and quality of life over time. This trial may suit those who have experienced CIPN for more than six months, suffer significant pain in their lower bodies, and have found little relief from standard pain medications. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must be on a stable pain medication regimen to participate.
What prior data suggests that spinal cord stimulation is safe for treating chemotherapy-induced peripheral neuropathy?
Research has shown that spinal cord stimulation (SCS) is generally safe for treating chronic pain. One study found that SCS is usually safe for people with long-term pain. However, reports have noted side effects, with most being serious and a few very serious. Despite this, SCS is widely used for various pain conditions and often proves effective. Participants should discuss potential risks with their healthcare provider to ensure SCS is the right choice for them.12345
Why are researchers excited about this trial?
Researchers are excited about spinal cord stimulation for chemotherapy-induced peripheral neuropathy because it offers a novel approach to managing pain and improving quality of life. Unlike standard treatments, which often rely on medications like antidepressants or anti-seizure drugs to alleviate symptoms, spinal cord stimulation targets pain directly by sending electrical impulses to the spinal cord. This method can potentially provide more effective relief without the side effects associated with conventional medications, making it a promising option for patients struggling with neuropathy.
What evidence suggests that spinal cord stimulation is effective for chemotherapy-induced peripheral neuropathy?
Research has shown that spinal cord stimulation (SCS) can help with various pain conditions. Studies indicate that SCS reduces pain more effectively than standard treatments for conditions like diabetic peripheral neuropathy, a nerve problem similar to that caused by chemotherapy. About 55% of patients with other non-cancer-related pain have experienced lasting relief with SCS. Although SCS has not been as effective for low back pain, its success in treating nerve-related pain suggests potential benefits for chemotherapy-induced nerve pain. This trial will observe patients receiving spinal cord stimulation therapy, offering hope that SCS could improve pain and quality of life for those with this type of nerve pain.678910
Who Is on the Research Team?
Ryan S. D'Souza, MD
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline questionnaires and assessments before starting spinal cord stimulation therapy
Treatment
Participants receive spinal cord stimulation therapy and complete questionnaires at 3, 6, and 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Spinal Cord Stimulation
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receiving spinal cord stimulation therapy complete questionnaires over 30 minutes at baseline and at 3, 6, and 12 months.
Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
- Phantom limb/stump pain
- Ischemic pain of vascular origin
- Complex regional pain syndrome
- Pain after an amputation
- Visceral abdominal pain and perineal pain
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
- Chronic pain
- Neuropathic pain
- Spinal cord injury pain
- Failed back surgery syndrome (FBSS)
- Adhesive arachnoiditis
- Peripheral causalgia/neuropathy
- Reflex sympathetic dystrophy (RSD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Spinal Cord Stimulation: Clinical Efficacy and Potential ...
Results in the SCS group were sustained over time, with 80% of patients using their devices and 55% of patients achieving treatment success at 5 years. Despite ...
Consecutive Transcutaneous and Epidural Spinal Cord ...
Compared with tSCS, following EES showed immediate improvement in voluntary movements, whereas tSCS was more effective in improving balance and posture.
Spinal Cord Stimulation vs Medical Management for ...
Analysis results suggest statistical superiority of conventional and novel SCS therapies over CMM in 5 of the 6 outcomes evaluated at 6-month ...
4.
sydney.edu.au
sydney.edu.au/news-opinion/news/2023/03/07/spinal-cord-stimulation-doesn-t-help-with-back-pain-says-new-rev.htmlSpinal cord stimulation doesn t help with back pain says ...
The review concluded that spinal cord stimulation is no better than a placebo for treating low back pain, with probably little to no benefit for people with ...
Non-invasive spinal cord electrical stimulation for arm and ...
Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA ( ...
Spinal cord stimulation is the application of mild electrical stimulation to the spinal cord to relieve chronic, intractable pain of the trunk and/or limbs.
Spinal Cord Stimulators: An Analysis of the Adverse Events ...
Five hundred twenty adverse events were reported for spinal cord stimulators. Most events were rated as severe (79%) or life-threatening (13%).
Cardiovascular safety of transcutaneous spinal cord ...
This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.
Long-term Safety of Spinal Cord Stimulation Systems in A ...
Results obtained from this prospective, real-world, international registry demonstrate an overall good safety profile with use of SCS systems for chronic pain ...
Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ...
Clinic and home-based ARC EX Therapy is safe and effectively improves upper extremity strength and function in people living with chronic, cervical SCI.
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