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Electrical Stimulation for Compression Neuropathy

WJ
Overseen ByWendy Jenkins, BSN RN, CCRC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

CD

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

I have nerve compression causing symptoms and need spine surgery to relieve it.
I have nerve compression in my arm and am planning surgery to relieve it.

Exclusion Criteria

Pregnant or nursing
Any implanted electronic devices, including pacemakers
I have not had nerve or tendon transfer surgery for my spinal cord injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Stimulation

Participants undergo decompressive surgery with intraoperative electrical stimulation using the Checkpoint Guardian device

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery and stimulation

1 year
Visits at Month 1, Month 3, and Year 1

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

Group I: Peripheral Nerve Stimulation ArmExperimental Treatment1 Intervention
Group II: Nerve Root Stimulation ArmExperimental Treatment1 Intervention
Group III: Peripheral Nerve Control ArmActive Control1 Intervention
Group IV: Nerve Root Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

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.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26342804/

Electrical Stimulation Threshold in Chronically ...

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Clinical applications of electrical stimulation for peripheral ...

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