Electrical Stimulation for Compression Neuropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether direct electrical stimulation during surgery can safely and effectively aid individuals with nerve problems from compressed nerves. It examines two types of electrical stimulation: Nerve Root Electrical Stimulation for nerves near the spine and Peripheral Nerve Electrical Stimulation for peripheral nerves in the arms. The trial includes different patient groups, with some undergoing spine surgery and others having surgery for nerve issues in their arms. Individuals experiencing nerve pain from compressed nerves and planning surgery may be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatments for nerve pain.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that electrical stimulation is safe for nerve decompression surgery?
Past studies have found both Nerve Root and Peripheral Nerve Electrical Stimulation to be generally safe for patients. Research shows that Peripheral Nerve Electrical Stimulation, used to treat chronic pain, often yields positive results, with most patients experiencing only mild side effects like skin irritation. Studies on Nerve Root Electrical Stimulation indicate safety when combined with other treatments. The FDA has approved both therapies for certain conditions, supporting their safety. Most patients tolerate these treatments well, and serious side effects are rare.12345
Why are researchers excited about this trial?
Researchers are excited about electrical stimulation for compression neuropathy because it offers a novel way to potentially enhance nerve recovery. Traditional treatments like medication, physical therapy, or surgery primarily focus on relieving pressure or symptoms. However, nerve root and peripheral nerve electrical stimulation use targeted electrical impulses to directly stimulate nerve repair and function. This unique approach could lead to faster and more effective recovery compared to conventional methods, offering hope for improved outcomes in patients undergoing nerve decompression surgeries.
What evidence suggests that this trial's electrical stimulation treatments could be effective for compression neuropathy?
This trial will compare Nerve Root Electrical Stimulation and Peripheral Nerve Electrical Stimulation for compression neuropathy. Studies have shown that electrical stimulation can assist with nerve issues. Specifically, research indicates that nerve root electrical stimulation can reduce pain levels and promote nerve healing, with one study reporting a decrease in pain from an average of 5.6 to 3.5. Peripheral nerve electrical stimulation also shows promise, with reports of 70-90% pain reduction and improved function. In some cases, two-thirds of patients experienced at least 50% pain relief. Both treatments in this trial are believed to aid by encouraging nerve healing and reducing pain.56789
Who Is on the Research Team?
Christopher Dibble, MD
Principal Investigator
Atrium Health Wake Forest Baptist
Are You a Good Fit for This Trial?
This trial is for people with nerve problems caused by Charcot-Marie-Tooth disease or compressed nerves who are having surgery. Participants must be eligible for standard surgical treatment and able to safely undergo electrical stimulation during the procedure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Stimulation
Participants undergo decompressive surgery with intraoperative electrical stimulation using the Checkpoint Guardian device
Follow-up
Participants are monitored for safety and effectiveness after surgery and stimulation
What Are the Treatments Tested in This Trial?
Interventions
- Nerve Root Electrical Stimulation
- Peripheral Nerve Electrical Stimulation
Trial Overview
The study compares standard surgical treatments with and without direct electrical stimulation of peripheral nerves or nerve roots during surgery, to see if adding stimulation improves outcomes.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
patients undergoing peripheral nerve decompression in an upper extremity
patients undergoing spine surgery for decompression of the nerve root
patients undergoing peripheral nerve decompression in an upper extremity
patients undergoing spine surgery for decompression of the nerve root
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Citations
Electrical stimulation therapy for peripheral nerve injury
The results showed that MCS was more effective than direct nerve stimulation in nerve regeneration and muscle nerve reinnervation, especially in ...
Intraoperative Peripheral Nerve Stimulation
The purpose of this research study is to find out if using direct electrical stimulation during surgery is safe and helpful for people with ...
Electrical stimulation therapy for peripheral nerve injury - PMC
Outcomes were no differences in mechanical pain threshold (MPT), heat pain threshold (HPT), tactile threshold (TT), and peripheral nerve conduction (PNC).
Year 2024 / Volume 35 / Number 1
The technique has demostrated short-term effectiveness in reducing musculoskeletal, neuropathic, or postoperative pain, as well as medication intake.
Electrical Stimulation Threshold in Chronically ...
Results: Chronically compressed nerve roots showed a higher stimulation threshold than non compressed nerve roots (11.93 mA vs. 4.33 mA). This difference ...
Transcutaneous electrical nerve stimulation (TENS) for ... - PMC
For adults with neuropathic pain, it is impossible to confidently state whether TENS is effective in relieving pain when compared to sham TENS.
Implantable Peripheral Nerve Stimulation for ...
The purpose of this review is to synthesize data from prospective studies on the efficacy of PNS for neuropathic pain as it pertains to pain intensity, ...
Ultrahigh frequency transcutaneous electrical nerve ...
This study aimed to validate the therapeutic effect of ultrahigh frequency (UHF)-TENS in chronic constriction injury of the rat sciatic nerve.
Clinical applications of electrical stimulation for peripheral ...
Although a relatively new therapy, ES has been demonstrated to be a safe and effective adjunctive therapy with established treatments including ...
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